Category Archives: 药你好看

一些药学方面的资讯,之所以叫“药你好看”,有一点原因是因为阅读这一分类下的文章可以说不用费脑细胞(以阅读闲书作为对照组)。

Salary Profiles in Pharmaceutical Enterprises in China

China is a big country, but salary profiles in pharmaceutical enterprises do not differ much from province to province and from city to city.

For new graduates of bachelor’s degree, the salary profiles can be concluded as:

  • 2000~2500 yuan RMB per month in Liaoning Province;
  • 2500~3000 yuan RMB per month in Jiangsu Provinces and Zhejiang Provinces;
  • 3000~3500 yuan RMB per month in Guangdong Province.

I do not know the salary profiles in other places in China. But I think the salary profiles in the above places are representative, because most of pharmaceutical enterprises in China are located in these places. For our convenience in the following text, we now assume that the salary for a new graduate of bachelor’s degree is 3000 yuan RMB per month.

To be honest, as a starting salary, 3000 yuan RMB per month seems very common, not low at all. The problem is, if you are not going to be a department leader, your salary will grow very slowly. It is a common case that if you do not skip to other enterprises, you salary will not grow to 4000 yuan RMB per month with three years’ work experience. If you are willing to skip to another pharmaceutical enterprise with a three years’ work experience, you can hope for a salary of 4000 yuan RMB per month – it will not be too hard to apply for a 4000 yuan RMB salary, however, it will be hard for you to get a work with salary higher than 5000 yuan RMB per month if you are not willing to be a department leader. This is because, 3000 yuan RMB guys are already competent enough for most work in pharmaceutical enterprises in China, 4000 yuan RMB guys can be called elites in pharmaceutical enterprises, and salary higher than 5000 yuan RMB per month is designated for department leaders.

As just said above, if you choose not to skip to another pharmaceutical enterprise, it will be hard for you with three years’ work experience to apply for a salary of 4000 yuan RMB per month, this is because the work you do is so simple that it is hard for you to demonstrate your ability. A pharmaceutical enterprise is a big system, staff in it are just like screws in a machine, you can always be substituted very easily. Therefore you know, most people are able to replace your position in a pharmaceutical company, which demonstrates that your work is very easy in some points. Not only you but also your company want you to be a staff of good ability, when your ability has nothing to do with your salary. Your ability becomes not so necessary, however, when it relates to your salary.

In many opinion, the basic salary profiles are determined by the supply and demand ratio of human resource of basic ability. The salary zone (elite salary zone) above the basic salary is determined by the supply and demand ratio of human resource of elites. Your ability determines your salary position in the salary zone above the basic salary. And there is a high salary zone above the elite salary zone. The high salary zone is for department leaders. There is a blank zone between the high salary zone and the elite salary zone. The blank zone is used to differentiate ordinary staff and leader staff in pharmaceutical enterprises.

Chinese pharmaceutical enterprises are still very young, for example, there are many pharmaceutical enterprises with history of only about 20 years. And you should know, although the turnover of young human resource is not low in pharmaceutical enterprises, the turnover of already-married human resource is actually very low. This is to say, that the turnover of leaders in pharmaceutical enterprises is quite low. However, leaders play important role in team building. A reasonable turnover value is quite important. Neither a too low or too high turnover value is appropriate.

药厂里的知识性比赛

滕运锋,2014年9月28日星期日,于东阳横店。标题《药厂里的知识性比赛》。

豆瓣上标记已读的书现在才86本,今年怕是想看到100本会有些困难了。还剩下三个月,每个月要看差不多5本。换句话说,一个星期至少要干掉一本书。要想完成任务,只能是专业书籍少看几本,闲书多看基本充充数了。

上周去东阳办了两次GMP证书的公证,第一次去的时候搭了HR部门马姐的顺风车,发现车里布置得很好啊,坐垫和地毯都很干净,播放的也不是什么吵吵闹闹的歌曲,是比较舒缓或轻快的那种。

前段时间听LCH说他那边有个今年新进来的应届毕业生和我是校友,叫LHH。而且她的室友ZLF也和我是校友。LHH在QC,ZLF在QA,都是我们公司以女性为大多数的部门。但是在此之前又听另外一个人说新区和研发部还有我的校友,所以感觉今年来了很多学弟学妹,打算等找齐了这些人再拉他们出来聚一下。但是今天问了公司HR部门的马姐,才知道事实上今年新来的只有两个校友,都是学妹,也就是段落开头提到的LHH和ZLF。不过一开始确定是她们两个的时候,发现她们的年龄分别比我大1岁和2岁,我是真的愣了一下,在那边想我是应该叫她们学妹呢,还是要喊姐呢?感觉学妹这个称呼可能不是很恰当。不过后来我上百度百科(虽然这并非是权威的网站,但是此刻我已懒得查字典了)里搜了一下,学妹就是指比自己低年级的女生。所以叫”学妹”是没有错的。当然,叫姐也是没错的。但好歹我是早他们一年进入职场的,叫姐感觉上是颇有些不对头的。

昨天有个GMP决赛,上次经理发票给我的时候,我是大吃一惊了,一听有个GMP决赛的门票给我,我以为是要让我去参加决赛。后来才知道是看别人决赛。但是去之前一直觉得这个决赛应该就是笔试吧,但是却需要观众,那估计就是抢答形式的了。不过实际到现场后,发现是有好几种提醒的。必答题(单选题)、多选题、判断题、CAPA题型(实际的题型叫什么名字我忘了)、抢答题、游戏题、风险题等题型。抢答题,顾名思义,就是那种拿抢答器抢答的类型。游戏题,类似于我们学生时代玩过的那种一个人做肢体语言让另外一个人猜某样东西的游戏,只不过公司这次是允许用口头语言和肢体语言的,这种情况下,用肢体语言的频次就很低了,大部分人都是用口头语言的,当然了,GMP决赛,不会让你猜小猫小狗什么的,猜的是”衣物柜”、”离心机”等药厂里常见的东西。风险题是每个小组可以自己选择是否作答,答对加分,打错扣分。这三个题型是比较出人意料的。反正这次的GMP决赛,比我预期得要精彩得多。尤其是里面这个CAPA题型,举的都是公司接受审计时碰到的实实在在的例子,让大家自己判断整改预防措施。还有些题目里有现场图片元素的加入。不过,我认为还是有几个地方可以改进的。

首先是多媒体元素上,这次有加入现场图片,我觉得这已经可以秒杀中国很多制药企业了,动动脚趾头都知道大部分制药企业如果要弄个GMP比赛,肯定只会是书面答题,其中还会有一大半都是只从《药品生产质量管理规范》正文+相关附录中选题。但是,既然已经有试过加入现场图片元素了,也可以加入现场视频元素。不一定都要是找错误,也可以是找优点。如果这次是实验操作比赛,也可以事先各位参赛选手自己录一段操作视频(并要求操作者在录制的时候故意做出1~2个失误,并将故意做出的失误上报裁判组),到时各位参赛选手依次看每个人的视频,发现一处错误加10分(几分自己定),由于每个选手碰到的视频所含有的错误数是1个还是2个是随机的,所以不管你碰到的视频是只有一个错误还是两个错误都是公平的。如果一个视频,其操作者只是故意犯了2个错误,找错者每发现一处错误加一次分,如果找出了操作者自己也没意识到的错误(也就是视频中出现了没有上报给裁判组的错误),会有额外加分。比赛中,裁判们会对每个选手的表现进行打分,但是分值只有1和2两种分值,1分表示一般(含较差),2分表示优秀(如果裁判认为该选手在观点、用词专业性、语言逻辑性等方面有什么闪光点的话,可以给2分),然后取所有裁判给出的分数的平均值的四舍五入结果作为所有裁判的综合给分,这样做有个好处,裁判给分会很省心,碰到自己觉得有闪光点的就给2分,不然就给1分,不会死掉什么脑细胞,但如果设置成三个分数级(比如0、1和2)来表示差、一般、优秀,就要多死一些脑细胞了,毕竟被认为”差”对答题者是有点打击的。在分值分配上,选手发现错误所加的分数要远大于裁判所能额外给的”选手表现分”,比如前者分配10分,后者分配1~2分。这样最终结果主要还是由选手的客观能力决定,裁判的主观”选手表现分”可能会对结果造成影响,但不会造成太大影响,而且由于裁判们的主观”选手表现分”基本上是要累计多次后才会对选手的排名产生影响,因为每一次的评分最多也就是造成两名选手之间1分的分差,不会影响大家的心情,也不易出现选手认为裁判判断不当。发现越写越长了,就这样收笔吧。以后如果自己有机会办个这样的活动,拿来参考参考,具体是需要细化和改动的,毕竟我这只是在空想,没有结合什么实际。

其次,反正已经邀请了观众,可以加入观众互动环节,比如说电视节目里的那种”场外求助”。每个队伍可以有自己的后援团,每个队伍有一定的场外求助机会可以向后援团求助。在每个队都有后援团的情况下,基本上不需要再额外邀请其他观众了。

再次,这次分值设计有待商榷。有些题型能明显感到大家的积极性不高。有些题目加分值为5分的话,扣分值不一定也要是5分,完全可以少扣一点,比如2分。这样积极性可能会高一点。

真得不能再写了,没完没了的。

2013年度中国医药工业百强企业排行榜

2014年7月5日,滕运锋,于东阳横店。数据看网上说是来源于“中国医药统计网”,反正在这个网站上我没找到具体文章,可能是在他们出的杂质里才能看到。榜单貌似是按主营业务收入排名的。

2013年度中国医药工业百强企业榜单
格式:排名.企业名称
1.广州医药集团有限公司
2.修正药业集团股份有限公司
3.扬子江药业集团有限公司
4.华润医药控股有限公司
5.中国医药集团总公司
6.威高集团有限公司
7.哈药集团有限公司
8.拜耳医药保健有限公司
9.天津市医药集团有限公司
10.石药集团有限责任公司
11.上海医药集团股份有限公司
12.辉瑞制药有限公司
13.齐鲁制药有限公司
14.华北制药集团有限责任公司
15.江西济民可信集团有限公司
16.上海罗氏制药有限公司
17.山东步长制药股份有限公司
18.中国远大集团有限责任公司
19.杭州华东医药集团有限公司
20.上海复星医药(集团)股份有限公司
21.诺和诺德(中国)制药有限公司
22.云南白药集团股份有限公司
23.四川科伦药业股份有限公司
24.珠海联邦制药股份有限公司
25.正大天晴药业集团股份有限公司
26.辅仁药业集团有限公司
27.江苏恒瑞医药股份有限公司
28.赛诺菲(杭州)制药有限公司
29.江苏豪森医药集团有限公司
30瑞阳制药有限公司
31.阿斯利康制药有限公司
32.绿叶投资集团有限公司
33.罗欣医药集团有限公司
34.菏泽睿鹰制药集团有限公司
35.人福医药集团股份公司
36.鲁南制药集团股份有限公司
37.北京四环制药有限公司
38.悦康药业集团有限公司
39.天士力控股集团有限公司
40.济川药业集团有限公司
41.西安杨森制药有限公司
42.丽珠医药集团股份有限公司
43.先声药业有限公司
44.江苏康缘集团有限责任公司
45.费森尤斯卡比(中国)投资有限公司
46.山德士(中国)制药有限公司
47.普洛药业股份有限公司
48.海南海药股份有限公司
49.寿光富康制药有限公司
50.东北制药集团有限责任公司
51.新和成控股集团有限公司
52.广西梧州中恒集团股份有限公司
53.北京诺华制药有限公司
54.天圣制药集团股份有限公司
55.江西青峰医药投资集团有限公司
56.华方医药科技有限公司
57.浙江海正药业股份有限公司
58.辰欣药业股份有限公司
59.回音必集团有限公司
60.浙江医药股份有限公司
61.江苏苏中药业集团股份有限公司
62.迪沙药业集团有限公司
63.中国通用技术(集团)控股有限责任公司
64.成都倍特药业有限公司
65.康恩贝集团有限公司
66.江苏亚邦药业集团股份有限公司
67.石家庄四药有限公司
68.安徽丰原集团有限公司
69.惠氏制药有限公司
70.深圳海王集团股份有限公司
71.江苏奥赛康药业股份有限公司
72.北京同仁堂健康药业股份有限公司
73.贵州益佰制药股份有限公司
74.双鸽集团有限公司
75.山东新华医药集团有限责任公司
76.西安力邦制药有限公司
77.上海创诺医药集团有限公司
78.石家庄以岭药业股份有限公司
79.重庆科瑞制药(集团)有限公司
80.四川好医生药业集团有限公司
81.黑龙江珍宝岛药业股份有限公司
82.海南卫康制药(潜山)有限公司
83.浙江仙琚制药股份有限公司
84.赛诺菲(北京)制药有限公司
85.深圳信立泰药业股份有限公司
86.江苏联环药业集团有限公司
87.太极集团有限公司
88.神威药业集团有限公司
89.四川百利药业有限责任公司
90.亚宝药业集团股份有限公司
91.百特(中国)投资有限公司
92.浙江华海药业股份有限公司
93.北京同仁堂科技发展股份有限公司
94.山东鲁抗医药股份有限公司
95.葵花药业集团股份有限公司
96.山东齐都药业有限公司
97.天津红日药业股份有限公司
98.北京同仁堂股份有限公司
99.北京泰德制药股份有限公司
100.广东广润集团有限公司

——————————以上榜单排名正文—————

———————————以下为个人分析——————

2013年度中国医药百强企业排行版中,我粗看了一下,大概有10家浙江药企(榜单里相应浙江药企已标为红色)。对应名单(含排名)如下:

19.杭州华东医药集团有限公司(2012年排名12,下降7位)

28.赛诺菲(杭州)制药有限公司(2012年排名23,下降5位)

47.普洛药业股份有限公司(2012年排名52,上升5位

51.新和成控股集团有限公司(2012年排名48,下降3位)

57.浙江海正药业股份有限公司(2012年排名65位,上升8位

59.回音必集团有限公司(2012年排名87位,上升28位

60.浙江医药股份有限公司(2012年排名47,下降13位)

65.康恩贝集团有限公司(2012年排名73,下降8位)

83.浙江仙琚制药股份有限公司(2012年排名88,上升5位

92.浙江华海药业股份有限公司(2012年排名95,上升3位

FDA2013年发布的483概要(FDA审计缺陷总结)

FDA

FDA 483报告(缺陷报告),也称现场观察报告(Inspectional Observation),它是FDA 检查官根据cGMP规范,对医药企业的质量体系进行现场检查过程中所发现的不符合cGMP 之处列出的总结清单。

Drugs

Center Name Cite Id Ref No Frequency Short Description Long Description
Drugs 1105 21 CFR 211.22(d) 155 Procedures not  in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed].  Specifically, ***
2027 21 CFR 211.192 131 Investigations of discrepancies, failures There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed.  Specifically, ***
1361 21 CFR 211.100(a) 106 Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.  Specifically, ***
3603 21 CFR 211.160(b) 99 Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity.  Specifically, ***
1215 21 CFR 211.67(b) 77 Written procedures not established/followed Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.  Specifically, ***
1451 21 CFR 211.113(b) 76 Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed].  Specifically, ***
1213 21 CFR 211.67(a) 71 Cleaning / Sanitizing / Maintenance Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to  prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product.  Specifically, ***
1883 21 CFR 211.165(a) 66 Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release.  Specifically, ***
3585 21 CFR 211.110(a) 65 Control procedures to monitor and validate performance Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.  Specifically, ***
1914 21 CFR 211.166(a) 62 Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.  Specifically, ***
1358 21 CFR 211.100(b) 59 SOPs not followed / documented Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance].  Specifically, ***
1274 21 CFR 211.68(a) 56 Calibration/Inspection/Checking not done Routine [calibration] [inspection] [checking] of  [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance.  Specifically, ***
2009 21 CFR 211.188 56 Prepared for each batch, include complete information Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch].  Specifically, ***
4314 21 CFR 211.84(d)(2) 53 Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals].  Specifically, ***
1177 21 CFR 211.63 49 Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of  drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance].  Specifically, ***
1112 21 CFR 211.25(a) 44 Training–operations, GMPs, written procedures Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations].  Specifically, ***
2419 21 CFR 211.198(a) 44 Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed].  Specifically, ***
1452 21 CFR 211.113(b) 43 Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include [adequate] validation of the sterilization process.  Specifically, ***
1890 21 CFR 211.165(e) 39 Test methods The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].  Specifically, ***
1111 21 CFR 211.25(a) 38 Training , Education , Experience overall Employees  engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions.  Specifically, ***
1133 21 CFR 211.25(a) 36 GMP Training Frequency GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them.  Specifically, ***
1809 21 CFR 211.160(a) 34 Following/documenting laboratory controls Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance].  Specifically, ***
1943 21 CFR 211.180(e)(1) 34 Review of representative number of batches Written procedures are not [established] [followed] for  evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.  Specifically, ***
4402 21 CFR 211.192 32 Written record of investigation incomplete Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] do not [always] include the conclusions and follow-up.  Specifically, ***
1159 21 CFR 211.28(a) 31 Clothing appropriate for duties performed Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not  appropriate for the duties they perform.  Specifically, ***
1434 21 CFR 211.42(c)(10)(iv) 31 Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.  Specifically, ***
1810 21 CFR 211.160(a) 29 Lab controls established, including changes The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, ***
1767 21 CFR 211.137(a) 28 Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.  Specifically, ***
2026 21 CFR 211.192 28 Quality control unit review of records Drug product production and control records, are not [reviewed] [approved] by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.  Specifically, ***
4389 21 CFR 211.198(a) 28 Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed].  Specifically, ***
1891 21 CFR 211.165(f) 27 Failing drug products not rejected Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected.  Specifically, ***
1885 21 CFR 211.165(b) 26 Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.  Specifically, ***
2028 21 CFR 211.192 26 Extent of discrepancy, failure  investigations Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications]  did not extend to [other batches of the same drug product] [other drug products that may have been associated with the specific failure or discrepancy].  Specifically, ***
2031 21 CFR 211.194(a) 26 Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.  Specifically, , ***
3632 21 CFR 211.170(b) 26 Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.  Specifically, ***
4303 21 CFR 211.67 b) 26 Written procedures fail to include Written procedures for cleaning and maintenance fail to include [assignment of responsibility] [maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and materials used] [description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or obliteration of previous batch identification] [instructions for protection of clean equipment from contamination prior to use] [parameters relevant to the operation].  Specifically, ***
4342 21 CFR 211.142(b) 26 Storage under appropriate conditions Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected.  Specifically, ***
4352 21 CFR 211.160(b)(4) 26 Calibration – at intervals, written program, remedial action The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals [in accordance with an established written program] [with provisions for remedial action in the event accuracy and/or precision limits are not met].  Specifically, ***
9001 21 CFR 211.22(a) 26 Lack of quality control unit There is no quality control unit.  Specifically, ***
1450 21 CFR 211.113(a) 25 Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed].  Specifically, ***
1787 21 CFR 211.80(a) 25 Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].  Specifically, ***
3572 21 CFR 211.100(b) 25 Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not [recorded] [justified].  Specifically, ***
1448 21 CFR 211.111 24 Establishment of time limitations Time limits are not established when appropriate  for the completion of each production phase to assure the quality of the drug product.  Specifically, ***
4391 21 CFR 211.180(e)(2) 23 Items to cover on annual reviews Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product].  Specifically, ***
4576 21 CFR 211.192 22 No written record of investigation Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications].  Specifically, ***
1920 21 CFR 211.166a)(3) 21 Valid stability test methods The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods.  Specifically, ***
1435 21 CFR 211.42(c)(10)(v) 20 Cleaning System Aseptic processing areas are deficient regarding the system for cleaning  and disinfecting the [room] [equipment] to produce aseptic conditions.  Specifically, ***
1833 21 CFR 211.84(d)(1) 20 Identity Testing of Each Component The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.  Specifically, ***
3559 21 CFR 211.56(a) 20 Sanitation–buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin]. Specifically, ***
1926 21 CFR 211.166(b) 18 Adequate number of batches on stability An adequate number of batches of each drug product are not tested [nor are records of such data maintained] to determine an appropriate expiration date.  Specifically, ***
1975 21 CFR 211.182 18 Written records kept in individual logs Written records of major equipment [cleaning] [maintenance] [use]  are not included in individual equipment logs.  Specifically, ***
3547 21 CFR 211.46(b) 18 Equipment for Environmental Control Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.  Specifically, ***
3565 21 CFR 211.58 18 Buildings not maintained in good state of repair Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair.  Specifically, ***
1033 21 CFR 211.22(a) 17 Authority lacking to review records, investigate errors The quality control unit lacks authority  to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred].  Specifically, ***
1263 21 CFR 211.68(b) 17 Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.  Specifically, ***
1912 21 CFR 211.166(a) 17 Written program not followed The written stability testing program is not followed.  Specifically, ***
3571 21 CFR 211.100(a) 17 Changes to Procedures Not Reviewed, Approved Changes to written procedures are  not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, ***
3602 21 CFR 211.160(a) 17 Deviations from laboratory control requirements Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified].  Specifically, ***
4413 21 CFR 211.194(a)(8) 17 Second person sign off Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for [accuracy] [completeness] [compliance with established standards].  Specifically, ***
1098 21 CFR 211.22(c) 16 Approve or reject procedures or specs The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products.  Specifically, ***
1550 21 CFR 211.125(f) 16 Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, ***
6732 21 CFR 314.80(c)(1)(i) 16 Late submission of 15-day report Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.  Specifically, ***
1194 21 CFR 211.42(c) 15 Defined areas of adequate size for operations The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, ***
1932 21 CFR 211.167(a) 15 Sterility/pyrogen-free testing Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements.  Specifically, ***
2008 21 CFR 211.186(a) 15 Written procedures followed Procedures for the preparation of master production and control records are not [described in a written procedure] [followed].  Specifically, ***
2619 21 CFR 211.198(b)(2) 15 Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].  Specifically, ***
3561 21 CFR 211.56(b) 15 Written sanitation procedures lacking There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing in sufficient detail the methods, equipment and materials to be used] for sanitation.  Specifically, ***
8907 21 CFR 314.81(b)(1)(ii) 15 Contamination, chemical or physical change, deterioration An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product.   Specifically, ***
1162 21 CFR 211.28(a) 14 Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.  Specifically, ***
1540 21 CFR 211.125(a) 14 Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.  Specifically, ***
4340 21 CFR 211.142 14 Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not [established] [followed].  Specifically, ***
4372 21 CFR 211.188(b)(8) 14 Labeling control records including specimens or copies Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.  Specifically, ***
1261 21 CFR 211.68(a) 13 Written calibration / inspection records not  kept Records of the [calibration checks] [inspections] of  automatic, mechanical or electronic equipment, including computers or related systems are not maintained.  Specifically, ***
2205 21 CFR 211.186(b)(9) 13 Manufacturing Instructions and Specifications The master production and control records are deficient in that they do not include complete [manufacturing] [control] [instructions] [sampling] [testing] [procedures] [specifications] [special notations] [precautions].  Specifically, ***
3616 21 CFR 211.165(d) 13 Acceptance criteria for sampling & testing Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet [each appropriate specification] [appropriate statistical quality control criteria] as a condition for their approval and release.  Specifically, ***
3629 21 CFR 211.170(b) 13 Reserve samples identified, representative, stored Reserve drug product samples  are not [appropriately identified] [representative of each lot or batch of drug product] [retained and stored under conditions consistent with product labeling].  Specifically, ***
4401 21 CFR 211.186(b)(9) 13 Complete instructions, procedures, specifications et. al. Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed].  Specifically, ***
17764 21 CFR 212.20(e) 13 Written QA procedures established, followed You did not [establish] [follow] written quality assurance procedures. Specifically,***
1086 21 CFR 211.22(b) 12 Adequate lab facilities not available Adequate lab facilities for testing and approval or rejection of [components] [drug product containers] [closures] [packaging materials] [in-process materials] [drug products] are not available to the quality control unit.  Specifically, ***
1227 21 CFR 211.67(c) 12 Cleaning/maintenance records not kept Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment.  Specifically, ***
1433 21 CFR 211.42(c)(10)(iii) 12 Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.  Specifically, ***
1942 21 CFR 211.180(e) 12 Records reviewed annually Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.  Specifically, ***
2007 21 CFR 211.186(a) 12 Signature and checking of records — 2 persons The master production and control records for each batch size of drug product are not  [prepared, dated, and signed by one person with a full handwritten signature] [independently checked, dated, and signed by a second person].  Specifically, ***
4336 21 CFR 211.150 12 Written distribution procedure Written distribution procedures are not [established] [followed].  Specifically, ***
4357 21 CFR 211.166(a) 12 Results not used for expiration dates, storage cond. Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates].  Specifically, ***
6730 21 CFR 314.80(b) 12 Failure to develop written procedures Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences. Specifically, ***
8911 21 CFR 314.81(b)(1)(ii) 12 Failure to meet specifications An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.   Specifically, ***
17812 21 CFR 212.50 12 Adequate controls (general) Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.  Specifically,***
1169 21 CFR 211.42(a) 11 Buildings of Suitable Size, Construction, Location Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations.  Specifically, ***
1395 21 CFR 211.103 11 Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of [manufacturing] [processing] [packaging] [holding] of the drug product.  Specifically, ***
1802 21 CFR 211.84(b) 11 Representative Samples Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination.  Specifically, ***
3570 21 CFR 211.100(a) 11 Approval and review of procedures Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit].  Specifically, ***
3583 21 CFR 211.110(a) 11 Written in-process control procedures Written procedures are not [established] [followed] that describe the [in-process controls] [tests] [examinations] to be conducted on appropriate samples of in-process materials of each batch.  Specifically, ***
1626 21 CFR 211.130 10 Procedures are written, and followed Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed].  Specifically, ***
1049 21 CFR 211.22(a) 9 Approve or reject components, products The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug product containers] [closures] [in process materials] [packaging material] [labeling] [drug products].  Specifically, ***
1270 21 CFR 211.68(b) 9 input/output verification Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy.  Specifically, ***
1505 21 CFR 211.122(d) 9 Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel.  Specifically, ***
1790 21 CFR 211.80(b) 9 Handling and Storage to Prevent Contamination There was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination.  Specifically, ***
1801 21 CFR 211.84(a) 9 Components withheld from use pending release Each lot of [components] [drug product containers] [closures] is not withheld  from use until the lot has been sampled, tested, examined, and released by the quality control unit.  Specifically, ***
4317 21 CFR 211.84(d)(3) 9 Certificates of Testing (Containers, Closures) Certificates of testing of [containers] [closures] are accepted in lieu of testing without [a visual identification] [establishing the reliability of the supplier’s test results through appropriate validation of the test results at appropriate intervals].  Specifically, ***
4406 21 CFR 211.194(a)(2) 9 Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use.  Specifically, ***
1134 21 CFR 211.25(b) 8 Supervisor Training/Education/Experience Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the  [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.  Specifically, ***
1136 21 CFR 211.25(c) 8 Inadequate number of  personnel The number of qualified  personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***
4338 21 CFR 211.150(b) 8 Recall facilitation A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.  Specifically, ***
1421 21 CFR 211.42(c)(10) 7 Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.  Specifically,***
1454 21 CFR 211.115(a) 7 Reprocessing procedures not written or followed Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are  not [written] [followed].  Specifically, ***
1869 21 CFR 211.94(c) 7 Containers & Closures Clean, Sterilized, Pyrogen-free Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use.  Specifically, ***
3591 21 CFR 211.110(b) 7 In-process materials specifications In-process specifications are not [consistent with drug product final specifications] [derived from previous acceptable process average and process variability estimates where possible] [determined by the application of suitable statistical procedures where appropriate].  Specifically, ***
3613 21 CFR 211.160(b)(4) 7 Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed].  Specifically, ***
4306 21 CFR 211.80(a) 7 Written Procedures Not Followed Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].  Specifically, ***
4315 21 CFR 211.84(d)(2) 7 Testing Each Component for Conformity with Specs Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically, ***
17763 21 CFR 212.20(d) 7 Determination need for investigation When errors occurred or a production batch failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary. Specifically,***
1163 21 CFR 211.28(b) 6 Habits of good sanitation & health Production personnel were not practicing good sanitation and health habits.  Specifically, ***
1844 21 CFR 211.84(d)(2) 6 Establish reliability of supplier’s C of A Establishment of the reliability of the component supplier’s report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.  Specifically, ***
1879 21 CFR 211.180(c) 6 Records not made readily available to FDA Records associated with drug product [components] [containers] [closures] [labeling] [production] [control] [distribution] and within the retention period for such records, were not made readily available for authorized inspection.  Specifically, ***
2012 21 CFR 211.188(b) 6 Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in [manufacturing] [processing] [packing] [holding].  Specifically, ***
4320 21 CFR 211.84(d)(6) 6 Microbiological Contamination Exam Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.  Specifically, ***
4324 21 CFR 211.110(b) 6 In-process materials specifications testing Examination and testing of samples is not done to assure that in-process materials conform to specifications.  Specifically, ***
4351 21 CFR 211.160(b)(3) 6 Drug products – samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified].  Specifically, ***
4359 21 CFR 211.170(a)(1), (b)(1) 6 Retention time of reserve samples, in general Reserve samples for [active ingredients] [drug products] are not retained for one year after the expiration date of the drug product.
4377 21 CFR 211.188(b(3) 6 Identification of each  component or in-process material Batch production and control records do not include the specific identification of each batch of [component] [in-process material] used for each batch of drug product produced.  Specifically, ***
6823 21 CFR 314.80(c) 6 Failure by applicant to report ADE Adverse drug experience information has not been reported to FDA.  Specifically, ***
17749 21 CFR 212.30(a) 6 Prevention of contamination Your facilities are not adequate to ensure the prevention of contamination of [equipment] [product] by [substances] [personnel] [environmental conditions] that could reasonably be expected to have an adverse effect on product quality.  Specifically,***
1266 21 CFR 211.42(d) 5 Penicillin processing area not  kept separate The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in facilities separate from those used for other drug products for human use.  Specifically,  ***
1495 21 CFR 211.122(a) 5 Written procedures describing in detail There is a lack of written  procedures describing in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of labeling and packaging materials.  Specifically, ***
1632 21 CFR 211.130(c) 5 Lot or control number assigned The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.  Specifically, ***
1728 21 CFR 211.87 5 Retest of approved components/containers/closures Approved [components] [drug product containers] [closures] are not retested or reexamined as appropriate for identity, strength, quality and purity after [storage for long periods] [exposure to conditions that might have an adverse effect]  with subsequent approval or rejection by the quality control unit.  Specifically, ***
1803 21 CFR 211.84(b) 5 Representative Samples Criteria The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria.  Specifically, ***
1886 21 CFR 211.165(c) 5 Sampling and testing plans not described Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of units per batch to be tested].  Specifically, ***
1918 21 CFR 211.166(a)(2) 5 Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing.  Specifically, ***
1976 21 CFR 211.182 5 Specific information required in individual logs Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].  Specifically, ***
2044 21 CFR 211.196 5 Distribution Record Requirements Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug product].  Specifically, ***
3557 21 CFR 211.52 5 Washing and toilet facilities are deficient Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness].  Specifically, ***
4302 21 CFR 211.56(b) 5 Written sanitation procedures not followed Written procedures for sanitation are not followed.  Specifically, ***
4350 21 CFR 211.160(b)(3) 5 Drug products-sampling procedures/specifications Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products.  Specifically, ***
4353 21 CFR 211.160(b)(4) 5 Instruments, apparatus, et. al. not meeting specs The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed.   Specifically, ***
4368 21 CFR 211.188(b)(12) 5 Investigations made into any unexplained discrepancy Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.  Specifically, ***
4378 21 CFR 211.188(b)(2) 5 Identity of major equipment and lines used Batch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product produced.  Specifically, ***
4382 21 CFR 211.198(b)(2) 5 Written record of complaint to include findings, follow-up Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up].  Specifically, ***
4418 21 CFR 211.42(b) 5 Adequate space lacking  to prevent mix-ups and contamination The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between [different components] [drug product containers] [closures] [labeling] [in-process materials] [drug products] and to prevent contamination.  Specifically, ***
6736 21 CFR 314.80(c)(1)(ii) 5 Submission of report follow-up Follow-up reports were not submitted [within 15 calendar days of receipt of new information] [as requested by FDA] concerning post marketing 15-day reports.  Specifically, ***
6831 21 CFR 314.80(c)(2) 5 Late submission of quarterly safety reports Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.  Specifically, ***
17722 21 CFR 212.10 5 Lack Adequate Resources, Facilities, Equipment. You lack adequate [resources] [facilities] [equipment] to enable your personnel to perform their functions.  Specifically, ***
1388 21 CFR 211.101(d) 4 Component addition checked by 2nd person Each component is not added to a batch by one person and verified by a second person.  Specifically, ***
1393 21 CFR 211.103 4 Yield calculations not verified by 2nd person Yield calculations are not performed by one person and independently verified by a second person.  Specifically, ***
1504 21 CFR 211.122(d) 4 Labels and labeling stored  separately Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.  Specifically, ***
1545 21 CFR 211.125(c) 4 Label reconciliation discrepancies evaluation/investigation Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated] [investigated].  Specifically, ***
1633 21 CFR 211.130(d) 4 Examination of packaging and labeling Examination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not documented in the batch production records].  Specifically, ***
1636 21 CFR 211.130(e) 4 Packaging line inspection before use Inspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all drug products have been removed from previous operations.  Specifically, ***
1774 21 CFR 211.142(a) 4 Quarantine – actual practice Drug products are not quarantined before being released by the quality control unit.  Specifically, ***
1777 21 CFR 211.150(b) 4 Distribution Recall System The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.  Specifically,  ***
1842 21 CFR 211.84(d)(1) 4 Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.  Specifically,***
1843 21 CFR 211.84(d)(2) 4 Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically,  ***
1868 21 CFR 211.94(b) 4 Protection from external factors Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.  Specifically, ***
1876 21 CFR 211.180(a), (b) 4 Record maintenance 1 year (except exempt OTC) All records of  [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product are not maintained at least one (1) year after the expiration date.  Specifically, ***
1917 21 CFR 211.166(a)(1) 4 Sample size – test intervals The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute examined to assure valid estimates of stability.  Specifically, ***
1922 21 CFR 211.166(a)(4) 4 Testing in same container – closure system The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.  Specifically, ***
1928 21 CFR 211.166(c)(1) 4 Homeopathic drugs, assessment of stability There is no written assessment of stability of homeopathic drug products based at least on [testing or examination of the drug product for compatibility of the ingredients] [marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use].  Specifically, ***
2003 21 CFR 211.184(c) 4 Individual inventory record Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product container] [drug product closure] with sufficient information to allow determination of any associated  batch or lot of drug product.  Specifically, ***
2033 21 CFR 211.194(c) 4 Testing and standardization of standards et. al. Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions].  Specifically, ***
2034 21 CFR 211.194(d) 4 Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices].  Specifically, ***
2567 21 CFR 211.198(a) 4 Adverse Drug Experience Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent [serious] [unexpected adverse drug experiences] which are required to be reported to FDA. Specifically, ***
2569 21 CFR 211.198(b) 4 Maintenance of Complaint File Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.  Specifically, ***
3445 21 CFR 211.65(a) 4 Equipment construction – reactive surfaces Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.  Specifically, ***
3594 21 CFR 211.110(d) 4 Rejected in-process materials not quarantined Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable.  Specifically, ***
4373 21 CFR 211.188(b)(7) 4 Actual yield, % of theoretical yield The batch production and control records do not include a statement of the [actual yield] [percentage of theoretical yield] at appropriate stages of processing for each batch of drug product produced.  Specifically, ***
4388 21 CFR 211.198(a) 4 Complaints reviewed by Quality Control Unit Written procedures describing the handling of complaints do not include provisions for [review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications] [a determination as to the need for an investigation of any unexplained discrepancy] [explaining the reasons for the failure of the batch or any of its components to meet specifications].  Specifically, ***
4399 21 CFR 211.186(b)(7) 4 Theoretical yield statement including percentages Master production and control records lack a statement of theoretical yield [including the maximum and minimum percentages of theoretical yield beyond which investigation is required].  Specifically, ***
4410 21 CFR 211.194(a)(5) 4 Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test.  Specifically, ***
6728 21 CFR 314.80(b) 4 Failure to review ADE information Adverse drug experience information obtained or otherwise received from any source was not [promptly] reviewed, including information from [commercial marketing experience] [post marketing clinical investigations] [post marketing epidemiological/surveillance activities] [reports in the scientific literature] [unpublished scientific papers].  Specifically, ***
17741 21 CFR 212.30(b) 4 Equipment not clean You did not implement procedures to ensure that all your equipment is clean.  Specifically, ***
17742 21 CFR 212.30(b) 4 Equipment not suitable You did not implement procedures to ensure that all your equipment is suitable for its intended purposes.  Specifically,***
17851 21 CFR 212.60(c) 4 Analytical methods Your laboratory analytical methods [are not suitable for their intended use] [are not sufficiently sensitive] [are not sufficiently specific] [are not accurate] [are not reproducible].  Specifically,***
1174 21 CFR 211.42(b) 3 Product flow through building is inadequate The flow  of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not designed to prevent contamination.  Specifically, ***
1722 21 CFR 211.134(a) 3 Correct labels during finishing operations Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.  Specifically, ***
1725 21 CFR 211.134(c) 3 Examinations documented The results of the examination of the packaged and labeled products were not documented in the batch production or control records.  Specifically, ***
1798 21 CFR 211.82(b) 3 Quarantine Storage of Components Incoming [components] [drug product containers] [closures] are not stored under quarantine until they have been tested or examined, as appropriate, and released.  Specifically, ***
1851 21 CFR 211.84(e) 3 Rejecting  When Specifications Not Met Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the appropriate written specifications for identity, strength, quality, and purity.  Specifically, ***
1927 21 CFR 211.166(b) 3 Accelerated stability studies Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not  supported with ongoing full shelf life studies.  Specifically, ***
1933 21 CFR 211.167(a) 3 Sterility/pyrogens – test methods written, followed Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed].  Specifically, ******
2035 21 CFR 211.194(e) 3 Stability testing records not  included Laboratory records do not include complete records of all stability testing performed.  Specifically, ***
3553 21 CFR 211.48(a) 3 Plumbing System Defects The plumbing system contains defects that could contribute to the  contamination of drug products.  Specifically, ***
3562 21 CFR 211.56(c) 3 Written procedures lacking for use of pesticides etc. Written procedures are lacking for the use of  [rodenticides] [insecticides] [fungicides] [fumigating agents] [cleaning and sanitizing agents] designed to prevent the contamination of [equipment] [components] [drug product containers] [closures] [packaging, labeling materials] [drug products].  Specifically, ***
3569 21 CFR 211.89 3 Quarantine of Rejected Components et. al. Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.  Specifically, ***
3582 21 CFR 211.105(a) 3 Identification of containers, lines, equipment All [compounding and storage containers] [processing lines] [major equipment] used during the production of a batch of drug product is not properly identified at all times to indicate [contents] [the phase of processing of the batch].  Specifically, ***
3611 21 CFR 211.160(b)(3) 3 Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products.  Specifically, ***
3614 21 CFR 211.160(b)(4) 3 Written calibration procedures Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions for remedial action if limits are not met].  Specifically, ***
3623 21 CFR 211.170(a) 3 Active ingredient retained sample kept A sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained].   Specifically, ***
3639 21 CFR 211.204 3 Returned drug procedures in writing and followed Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed].  Specifically, ***
4305 21 CFR 211.68(b) 3 Backup data not assured as exact and complete Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems.  Specifically, ***
4328 21 CFR 211.122(a) 3 Written procedures not followed Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed.  Specifically, ***
4330 21 CFR 211.130(e) 3 Packaging line inspection documentation Results of inspection of packaging and labeling facilities are not documented in the batch production records.  Specifically, ***
4343 21 CFR 211.160(b)(1) 3 Incoming lots – conformance to written specs- Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] used in the manufacture, processing, packing, or holding of drug products.  Specifically, ***
4344 21 CFR 211.160(b)(1) 3 Sampling and testing procedures described Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used.  Specifically, ***
4356 21 CFR 211.166(b) 3 Tentative expiration date Where data from accelerated studies was used to project a tentative expiration date beyond a date supported by actual shelf life studies, there were no [stability studies] [drug product testing at appropriate intervals] conducted until the tentative expiration date was verified or the appropriate expiration date determined.  Specifically, ***
4369 21 CFR 211.188(b)(11) 3 Identification of persons involved, each significant step Batch production and control records do not include the identification of the persons [performing] [directly supervising] [checking] each significant step in the operation, for each batch of drug product produced.  Specifically, ***
4371 21 CFR 211.188(b)(9) 3 Description of containers and closures Batch production and control records do not include a description of drug product [containers] [closures] used for each batch of drug product produced.  Specifically, ***
4400 21 CFR 211.186(b)(8) 3 Description of containers, labels, et. al. Master production and control records lack [a description of the drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling] [the signatures and dates entered by the person or persons responsible for the approval of labeling].  Specifically, ***
4404 21 CFR 211.194(a)(1) 3 Sample identification and other information Laboratory records do not include [a description of the sample received for testing] [the source or location from where the sample was obtained] [the quantity of the sample] [the lot number or other distinctive code of the sample] [the date the sample was taken] [the date the sample was received for testing].  Specifically, ***
4409 21 CFR 211.194(a)(4) 3 Data secured in course of each test Laboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product tested].  Specifically, ***
6832 21 CFR 314.80(c)(2) 3 Late submission of annual safety reports Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.  Specifically, ***
6842 21 CFR 314.80(i) 3 Failure to maintain records Records relating to all adverse drug experiences known to you, including raw data and any correspondence, have not been maintained for the required ten year period.  Specifically, ***
8912 21 CFR 314.81(b)(2) 3 Timely submission An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval of the application] to the FDA division responsible for reviewing the application.   Specifically, ***
17850 21 CFR 212.60(b) 3 Lab sampling and test procedures Each laboratory did not have sampling procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,***
17932 21 CFR 212.60(b) 3 Testing Procedures- Conformance to Standards Each laboratory did not have testing procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,***
17940 21 CFR 212.71(a) 3 Non-Conforming Product Investigation Incomplete The investigation of the cause of the nonconforming batch of a PET drug product did not include examination of the [processes] [operations] [records] [complaints] [other relevant sources of information] concerning the nonconforming product. Specifically***
1079 21 CFR 211.22(a) 2 Contract drug products–lack of responsibility The quality control unit lacks responsibility for approving or rejecting drug products [manufactured] [processed] [packed] [held] under contract by another company.  Specifically, ***
1218 21 CFR 211.67(b)(1) 2 Cleaning SOP/responsibility Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.  Specifically, ***
1413 21 CFR 211.42(c)(5) 2 Mfg / Processing Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.  Specifically, ***
1430 21 CFR 211.42(c)(10)(i) 2 Floors, walls, ceiling surfaces Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,***
1449 21 CFR 211.111 2 Deviations of production time limits Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product].  Specifically, ***
1456 21 CFR 211.115(b) 2 Reprocessing/quality control unit Reprocessing  was  performed without the [review] [approval] of the quality control unit.  Specifically, ***
1496 21 CFR 211.122(a) 2 Sampling/testing of labeling/packaging materials Labeling and packaging materials are not  [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product.  Specifically, ***
1629 21 CFR 211.130(a) 2 Prevention of cross contamination, mix-ups There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.  Specifically, ***
1630 21 CFR 211.130(b) 2 Unlabeled filled containers controls Filled drug product containers which are set aside and held in an unlabeled condition are not [identified] [handled] to preclude mislabeling of individual containers, lots or portions of lots.  Specifically, ***
1637 21 CFR 211.130(e) 2 Packaging line inspection after use Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.  Specifically, ***
1724 21 CFR 211.134(b) 2 Representative samples after completion Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations.  Specifically, ***
1791 21 CFR 211.80(c) 2 Storage off Floor, Spaced Suitably Bagged or boxed components of drug product [containers] [closures] are not [stored off the floor] [suitably spaced to allow cleaning and inspection].  Specifically, ***
1797 21 CFR 211.82(a) 2 Examination on receipt, before acceptance Each container or grouping of containers of [components] [drug product containers] [closures] is not examined visually upon receipt and before acceptance for [appropriate labeling as to contents] [container damage] [broken seals]  [contamination]. Specifically, ***
1846 21 CFR 211.84(d)(3) 2 Establish reliability of supplier’s C of A Establishment of the reliability of the [container] [closure] supplier’s report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.  Specifically, ***
1958 21 CFR 211.180(f) 2 Responsible firm officials notified in writing Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions,  are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices].  Specifically, ***
1978 21 CFR 211.182 2 Personnel  dating/signing equipment log The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log.  Specifically, ***
2014 21 CFR 211.188(b)(2) 2 Identification of Equipment and Lines The batch production and control records are deficient in that they do not  include the identity of major [equipment] [lines] used.  Specifically, ***
2196 21 CFR 211.186(b)(1) 2 Product Name and Strength The master production and control records are deficient in that they do not  include the [name] [strength] of the drug product and a description of the dosage form.  Specifically, ***
2401 21 CFR 211.194(a)(4) 2 Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.  Specifically, ***
3548 21 CFR 211.46(c) 2 Air filtration system lacking in production area The production area air supply lacks an appropriate air filtration system.  Specifically, ***
3550 21 CFR 211.46(c) 2 Exhaust systems inadequate to control air contamination Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.  Specifically, ***
3551 21 CFR 211.46(d) 2 Penicillin air handling systems not kept separate Air-handling systems for the [manufacture] [processing] [packing] of penicillin are not completely separate  from those for other drug products for human use.  Specifically, ***
3573 21 CFR 211.101(b) 2 Measured components for manufacturing Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate].  Specifically, ***
3581 21 CFR 211.101(d) 2 Verification of component addition Each component is not added to the batch by one person and verified by a second person..  Specifically, ***
3588 21 CFR 211.110(a)(3) 2 Mixing adequacy The in process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.  Specifically, ***
3592 21 CFR 211.110(c) 2 In-process materials characteristics testing In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by the quality control unit [during the production process] [after storage for long periods]. Specifically, ***
3610 21 CFR 211.160(b)(3) 2 Drug product sample Drug product samples are not [representative of the entire batch] [properly identified].  Specifically, ***
3631 21 CFR 211.170(b) 2 Investigation of reserve sample deterioration Evidence of reserve drug product sample deterioration was not  [investigated] [recorded and maintained with other stability data].  Specifically, ***
4304 21 CFR 211.68(b) 2 Written record not kept of program and validation data A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.  Specifically, ***
4307 21 CFR 211.80(d) 2 Status of Each Lot Identified Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its status in terms of being quarantined, approved or rejected.  Specifically, ***
4345 21 CFR 211.160(b)(1) 2 Samples (various types) representative, identified properly Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [labeling] are not [representative] [adequately identified].  Specifically, ***
4355 21 CFR 211.165(c) 2 Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product.  Specifically, ***
4360 21 CFR 211.170(b) 2 Reserve drug product sample quantity – all tests The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product.  Specifically, ***
4366 21 CFR 211.188(a) 2 Accurate reproduction included Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was  checked for accuracy, dated and signed.  Specifically, ***
4374 21 CFR 211.188(b)(6) 2 Inspection of packaging and labeling area Batch production and control records do not include results of the inspection of the packaging and labeling area [before] [after] use for each batch of drug product produced.  Specifically, ***
4383 21 CFR 211.198(b)(1) 2 Written complaint record must include Written complaint records do not include, where known, [the name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant].  Specifically, ***
4386 21 CFR 211.198(b) 2 Written complaint record  to be maintained at facility A written record of each complaint is not maintained in a file designated for drug product complaints [at the facility where the drug product was manufactured, processed or packed] [at a facility other than the facility in which the drug product was manufactured, processed or packed provided the written records are readily available for inspection at that other facility].  Specifically, ***
4403 21 CFR 211.194(b) 2 Test method modification records do not  include Records maintained of any modification of an established method employed in testing do not include [the reason for the modification] [the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method].  Specifically, ***
4405 21 CFR 211.194(a)(2) 2 Statement of methods and data Laboratory records do not include a statement of [each method used in the testing of a sample] [the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested].  Specifically, ***
4415 21 CFR 211.204 2 Returned drug products with doubt cast as to safety et. al. Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not [destroyed] [subjected to examination, testing or other investigation to prove the drug products do meet all the necessary parameters].  Specifically, ***
4416 21 CFR 211.204 2 Reprocessed returned drug products Returned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety, identity, strength, quality and purity.  Specifically, ***
6735 21 CFR 314.80(c)(1)(ii) 2 Failure to investigate serious, unexpected events Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated.  Specifically, ***
6830 21 CFR 314.80(c)(2) 2 Interval Periodic reports of non-alert adverse drug experiences have not been submitted [quarterly for an application which was approved less than three years ago] [yearly for an application which was approved three or more years ago].  Specifically, ***
6833 21 CFR 314.80(c)(2)(ii) 2 Incomplete periodic safety report Not all periodic reports contained [a narrative summary and analysis of the information in the report] [an analysis of the post marketing 15-day Alert reports submitted during the reporting interval] [an FDA Form 3500A for each adverse drug experience not reported as a post marketing 15-day Alert report] [an index containing a line listing of your patient identification number and adverse reaction term(s)] [a history of actions taken since the last report because of adverse drug experiences].  Specifically, ***
8935 FDCA 760(b)(1) 2 Failure of responsible person to report AE (non-RX Drug) Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to the Secretary. Specifically, ***
17743 21 CFR 212.30(b) 2 Equipment procedures overall You did not implement procedures to ensure that all your equipment is [properly installed] [maintained] [capable of repeatedly producing valid results].  Specifically,***
17745 21 CFR 212.30(b) 2 Equipment not properly maintained You did not document your activities in accordance with your procedures for ensuring the equipment suitability for its intended purposes.  Specifically,***
17755 21 CFR 212.20(a) 2 Oversight of production operations You did not oversee production operations in a manner to ensure that each PET drug [meets the requirements of the FD&C Act as to safety] [has the identity and strength that it is supposed to have] [meets the quality and purity characteristics that it is supposed to have].  Specifically, ***
17769 21 CFR 212.40(a) 2 Content of written procedures You did not [establish] [maintain] [follow] appropriate written procedures that describe the [receipt] [login] [identification] [storage] [handling] [testing] [acceptance and/or rejection] of [components] [drug product containers] [closures].  Specifically,***
17772 21 CFR 212.40(b) 2 Written specs  – components You did not establish appropriate written specifications for the [identity] [quality] [purity] of components.  Specifically,***
17813 21 CFR 212.50(a) 2 Written control procedures You did not have written production and process control procedures to [ensure] [document] that [all key process parameters are controlled] [any deviations from the procedures are justified].  Specifically,***
17842 21 CFR 212.50(d) 2 Records of checks made You did not keep a record of checks of the [production area] [all equipment in the production area] for cleanliness and suitability immediately before use.  Specifically,***
17849 21 CFR 212.60(a) 2 Testing procedures Each laboratory used to conduct testing of [components] [in-process materials] [finished PET drug products] does not [have written procedures] [follow written procedures] for the conduct of each test.  Specifically,***
17858 21 CFR 212.60(f) 2 Documenting procedures You did not document the [calibration] [inspection] [checking] [maintenance] of laboratory equipment. Specifically,***
17859 21 CFR 212.60(g) 2 Test records complete (general) Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays. Specifically,***
17883 21 CFR 212.70(d)(3) 2 Final dated signature You did not [establish] [follow] procedures to ensure that a PET drug was not given final release before a designated qualified individual authorized the final release by dated signature.  Specifically,***
1167 21 CFR 211.34 1 Qualifications lacking Consultants lack sufficient education, training and experience to advise on the subject for which they are retained.  Specifically, ***
1168 21 CFR 211.34 1 Consultant Records Records are not maintained stating the consultant’s [name] [address] [qualifications] [type of service provided].  Specifically, ***
1219 21 CFR 211.67(b)(2) 1 Cleaning SOPs/schedules Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.  Specifically, ***
1220 21 CFR 211.67(b)(3) 1 Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.  Specifically, ***
1222 21 CFR 211.67(b)(4) 1 Cleaning SOPs/equipment identification Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch identification.  Specifically, ***
1224 21 CFR 211.67(b)(6) 1 Cleaning SOP/inspection Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.  Specifically, ***
1251 21 CFR 211.42(c)(1) 1 Incoming material area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of [components] [drug product containers] [closures] [labeling] pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.  Specifically, ***
1256 21 CFR 211.68(b) 1 Backup file not maintained Failure to maintain a backup file of data entered into the computer or related system.  Specifically, ***
1371 21 CFR 211.101(a) 1 Batches Formulated to less than 100% Written production and control procedures  include batches formulated with the intent to provide less than  100 percent of the labeled or established amount of active ingredient.  Specifically, ***
1384 21 CFR 211.101(c) 1 Weighing/measuring/subdividing operations Component [weighing] [measuring] [subdividing] operations are not adequately supervised.  Specifically, ***
1396 21 CFR 211.42(c)(2) 1 Rejected Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition.  Specifically,***
1411 21 CFR 211.105(b) 1 Distinctive ID or code not recorded in batch record The batch records do not record the distinctive [identification number] [code] [name of equipment]  to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.  Specifically, ***
1418 21 CFR 211.42(c)(7) 1 Quarantined Drug Products Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.  Specifically, ***
1431 21 CFR 211.42(c)(10)(ii) 1 Temperature / Humidity Controls Aseptic processing areas are deficient regarding [temperature] [humidity]  controls.  Specifically, ***
1436 21 CFR 211.42(c)(10)(vi) 1 Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.  Specifically, ***
1509 21 CFR 211.122(h) 1 Printing devices Printing devices used to imprint labeling upon the drug product [unit label] [case] are  not monitored to assure that all imprinting conforms to the print specified in the batch production record. Specifically, ***
1726 21 CFR 211.86 1 Rotation of components/containers/closures There is a lack of rotation so that the oldest approved stock of [components] [drug product containers] [closures] is used first.  Specifically, ***
1794 21 CFR 211.80(d) 1 Disposition recorded by lot identification The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot.  Specifically, ***
1796 21 CFR 211.80(d) 1 Identification of Each Lot in Each Shipment Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for [components] [drug product containers] [closures].  Specifically, ***
1818 21 CFR 211.84(c)(2) 1 Appropriate Opening of Component Containers The containers of components, or drug product containers or closures which are sampled are not opened in a manner to prevent [contamination of their contents] [contamination of other components] [contamination of other drug product containers] [contamination of other closures].  Specifically, ***
1824 21 CFR 211.84(c)(5) 1 Identifying Sample Containers Sample container identification of sampled item is deficient in that it does not include the [name of the material sampled] [lot number] [container from which the sample was taken] [date on which the sample was taken] [name of the person who collected the sample].   Specifically, ***
1845 21 CFR 211.84(d)(3) 1 Container/Closure Written Test Procedure Drug product container and closure test procedures are deficient in that [containers] [closures] are not tested for conformance in accordance with  appropriate written procedures.  Specifically,  ***
1849 21 CFR 211.84(d)(6) 1 Objectionable microbiological contamination Each lot of a [component] [drug product containers] [closures] liable to objectionable  microbiological contamination is deficiently subjected to microbiological tests before use.  Specifically,  ***
1852 21 CFR 211.94(a) 1 Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are [reactive] [additive] [absorptive] so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.  Specifically, ***
1870 21 CFR 211.94(d) 1 Written Procedures to Remove Pyrogens There are no written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilization] [methods of processing] to remove pyrogenic properties.  Specifically, ***
1938 21 CFR 211.167(c) 1 Controlled release dosage form testing Each batch  of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient.  Specifically, ***
1941 21 CFR 211.180(d) 1 Reader/Photocopy equipment not made  available Suitable reader or photocopying equipment was not made readily available for [drug product] [component] records maintained using reduction techniques.  Specifically, ***
1957 21 CFR 211.180(e)(2) 1 Review of problem drugs The procedures for the annual quality standards record evaluation are deficient in that they do not  address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation] records for each drug product.  Specifically, ***
1999 21 CFR 211.184(a) 1 Record information required The records for [components] [drug product containers or closures] [labeling]  do not include the [identity and quantity of each shipment of each lot] [name of the supplier] [supplier’s lot number]  [receiving code] [date of receipt] [name of the prime manufacturer if different from the supplier] [location of the prime manufacturer].  Specifically, ***
2020 21 CFR 211.188(b)(8) 1 Labeling Control Records and Label Copies The batch production and control records are deficient in that they do not  include [complete labeling control records] [specimen] [copy] of labeling.  Specifically, ***
2023 21 CFR 211.188(b)(11) 1 Identification of Persons Performing Significant Steps The batch production and control records are deficient in that they do not include identification of persons [performing] [supervising] [checking] each significant step in the operation.  Specifically, ***
2200 21 CFR 211.186(b)(4) 1 Variation in the Amount of Components Used The master production and control records are deficient in that they lack a justification for the variation in the amount of components used in the preparation of a dosage form.  Specifically, ***
2201 21 CFR 211.186(b)(5) 1 Calculated Excess of Components Used The master production and control records are deficient in that they do not include a statement concerning any calculated excess of component. Specifically, ***
2402 21 CFR 211.194(a)(5) 1 Testing Calculations Laboratory records are deficient in that they do not include all calculations performed during testing.  Specifically, ***
2406 21 CFR 211.194(a)(8) 1 Identification of Person Performing Review of Lab Records Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy.  Specifically, ***
2420 21 CFR 211.198(a) 1 Quality Control Review Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit.  Specifically, ***
2572 21 CFR 211.198(b) 1 Complaint File Location Complaint procedures are deficient in that written complaint files are not maintained at the manufacturing site nor were they readily available from their off-site location.  Specifically, ***
2621 21 CFR 211.198(b)(3) 1 Reason for Not Conducting Complaint Investigation Complaint records are deficient in that they do not document the reason and the individual  making the decision not to conduct a complaint investigation.  Specifically, ***
3554 21 CFR 211.48(a) 1 Potable water standards not met The potable water being permitted for use in the potable water system fails to meet  standards prescribed by the Environmental Protection Agency.  Specifically, ***
3558 21 CFR 211.52 1 Washing and toilet facilities not provided and accessible Washing and toilet facilities are not [provided] [easily accessible to working areas].  Specifically, ***
3567 21 CFR 211.84(d)(2) 1 Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier’s report of analysis.  Specifically, ***
3597 21 CFR 211.122(g)(3) 1 Visual inspection The packaging and labeling operation involving cut labels and relying on visual inspection does not provide for [100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling] [examination to be performed by one person and independently verified by a second person].  Specifically, ****
3630 21 CFR 211.170(b) 1 Drug product reserve containers Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate container-closure system that has essentially the same characteristics as the marketed product].  Specifically, ***
4310 21 CFR 211.84(c)(3) 1 Sterile Equipment, Aseptic Techniques in sample collecting Failure to use [sterile equipment] [aseptic sampling techniques] when necessary in collecting a sample.  Specifically, ***
4313 21 CFR 211.84(c)(6) 1 Containers Marked to Show Samples Taken Containers from which samples have been taken are not marked to show that samples have been taken from them.  Specifically, ***
4316 21 CFR 211.84(d)(3) 1 Testing Containers & Closures Conformity with Specs Containers and closures are not tested for conformance with all appropriate written procedures.  Specifically, ***
4322 21 CFR 211.101(d) 1 Component release checked by 2nd person Each container of component dispensed to manufacturing is not examined by a second person to assure that [the component was released by the quality control unit] [the weight or measure is correct as stated in the batch records] [the containers are properly identified].  Specifically, ***
4325 21 CFR 211.110(a) 1 Control procedures fail to include the following Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of solutions].  Specifically,***
4349 21 CFR 211.160(b)(2) 1 In-process samples representative, identified properly Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified].  Specifically, ***
4354 21 CFR 211.165(d) 1 Acceptance/Rejection Levels The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].  Specifically, ***
4370 21 CFR 211.188(b)(10) 1 Records of any sampling performed Batch production and control records do not include a record of any sampling performed, for each batch of drug product produced.  Specifically, ***
4375 21 CFR 211.188(b)(5) 1 In-process and laboratory control results Batch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced.  Specifically, ***
4376 21 CFR 211.188(b)(4) 1 Weights and measures of components used Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced.  Specifically, ***
4379 21 CFR 211.188(b)(1) 1 Dates not included for each significant step Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the batch for each batch of drug product produced.  Specifically, ***
4387 21 CFR 211.198(a) 1 Reporting of adverse drug experience to FDA Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration.  Specifically, ***
4390 21 CFR 211.180c) 1 Photocopying of records not allowed Records or copies of records were not made  available for photocopying or other means of reproduction.  Specifically, ***
4411 21 CFR 211.194(a)(6) 1 Test results, comparison with standards not included Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the [component] [drug product container] [closure] [in-process material] [drug product] tested.  Specifically, ***
4412 21 CFR 211.194(a)(7) 1 Signatures and dates–person who performs test Laboratory records do not include [the initials or signature of the person who performs each test] [the date(s) the tests were performed].  Specifically, ***
4414 21 CFR 211.204 1 Record information maintained Records of returned drug products are not maintained.  Specifically, ***
6825 21 CFR 314.80(c)(1)(iii) 1 Non-applicant reports to applicant You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both serious and unexpected.  However, you did not submit each report to the applicant [within five calendar days of your receipt of the information].  Specifically, ***
6827 21 CFR 314.80(c)(1)(iv) 1 Failure to identify report content Each post marketing 15-day Alert report submitted to FDA did not have its contents prominently identified, i.e. [post marketing 15-day report] [post marketing 15-day report follow-up].  Specifically, ***
6829 21 CFR 314.80(c)(2) 1 Failure to report non-alert ADEs Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report.  Specifically, ***
6835 21 CFR 314.80(d)(1) 1 Failure to submit scientific article Not all post marketing 15-day Alert reports based upon scientific literature were accompanied by a copy of the published article.  Specifically, ***
6838 21 CFR 314.80(e)(1) 1 Failure to report post-marketing study ADEs Fifteen-day Alert reports have not been submitted for all adverse drug experiences during post marketing studies, where there was a reasonable possibility that the drug caused the adverse experience.  Specifically, ***
8914 21 CFR 314.81(b)(2)(iv)(b) 1 Mfg and control changes not requiring a supplemental app. An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.   Specifically, ***
8922 21 CFR 314.81(b)(2)(viii) 1 Post marketing study status report for other studies An annual report did not include a status report for all post marketing studies being performed by, or on behalf of, the applicant and not covered by the requirements of 21 CFR 314.81(b)(2)(vii).  Specifically, ***
17002 FDCA 501(a) 1 Drug Field Exam During a field examination of drug products at your facility the following [was] [were] observed:
17744 21 CFR 212.30(b) 1 Equipment not properly installed You did not document your activities in accordance with your procedures for cleaning all of your equipment.  Specifically,***
17753 21 CFR 212.30(c) 1 Contact surfaces Your equipment is not [constructed] [maintained] so that surfaces that contact [components] [in-process materials] [PET drugs] are not reactive, additive, or absorptive so as to alter the quality of the PET drugs.  Specifically,***
17757 21 CFR 212.20(b) 1 Examine, approve or reject You did not approve or reject [components] [containers] [closures] [in-process materials] [packaging materials] [labeling] [finished dosage forms] in a manner that ensures compliance with procedures and specifications affecting the identity, strength, quality or purity of a PET drug.  Specifically,***
17761 21 CFR 212.20(c) 1 Proposed changes to existing specs/methods You did not approve or reject, before implementation, proposed changes to existing [specifications] [methods] [processes] [procedures] to ensure that they would maintain the identity, strength, quality and purity of a PET drug.  Specifically,***
17765 21 CFR 212.20(d) 1 Review of records for errors You did not review production records to determine whether errors had occurred.  Specifically,***
17770 21 CFR 212.40(a) 1 Suitable for intended use Your written procedures are not adequate to ensure that the [components] [containers] [closures] are suitable for their intended use.  Specifically,***
17821 21 CFR 212.50(b)(6) 1 Action limits on radiochemical yield Your master production and control records did not contain a statement of action limits on radiochemical yield.  Specifically,***
17822 21 CFR 212.50(b)(7) 1 Complete instructions, procedures, specs Your master production and control records did not contain [complete production and control instructions] [complete sampling and testing procedures] [complete specifications] [special notations] [precautions to be followed].  Specifically,***
17823 21 CFR 212.50(b)(8) 1 Container & label descriptions Your master production and control records did not contain [a description of the PET drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling].  Specifically,***
17832 21 CFR 212.50(c)(4) 1 Each major production step Your batch production records do not [always] include each major production step (obtained from the approved appropriate master production and control record).  Specifically,***
17846 21 CFR 212.50(f)(2) 1 Documentation of activities You did not document your process verification [activities] [results].  Specifically,***
17853 21 CFR 212.60(d) 1 Supplies adequately controlled Your [reagents] [solutions] [supplies] used in your testing procedures are not adequately controlled.  Specifically,***
17855 21 CFR 212.60(e) 1 Equipment All equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing valid results].  Specifically,***
17865 21 CFR 212.60(g)(5) 1 Initials, signature, date Laboratory test records did not contain the initials or signature of the person performing the test. Specifically,***
17869 21 CFR 212.61(a) 1 Samples representative, stored properly The samples tested for stability were [not representative of the lot or batch from which they were obtained] [not stored under suitable storage conditions].  Specifically,***
17870 21 CFR 212.61(b) 1 Use of stability test results The stability test results were not [documented] [used in determining appropriate storage conditions] [used in determining appropriate expiration dates and times] for each PET drug product you produce.  Specifically,***
17872 21 CFR 212.70(a) 1 Specifications You did not establish [adequate] specifications for each PET drug product, including criteria for determining [identity, strength, quality and purity] [sterility] [pyrogens].  Specifically,***
17874 21 CFR 212.70(b) 1 Before implementing new procedure establish accuracy etc. You implemented a new test procedure in a specification, but you did not first [establish] [document] the [accuracy] [sensitivity] [specificity] [reproducibility] of the procedure.  Specifically,***
17877 21 CFR 212.70(c) 1 Conform to specs prior to release You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug conforms to specifications before final release.  Specifically,***
17886 21 CFR 212.70(e) 1 When 30 hour rule is exceeded A sample for sterility testing was held longer than 30 hours, but you did not demonstrate that the longer period did not adversely affect the sample and that the test results obtained were equivalent to test results that would have been obtained if the test had been started within the 30 hour period.  Specifically,***
17896 21 CFR 212.71(a) 1 Rejection of nonconforming product You did not reject the batch of a PET drug product that did not conform to specifications.  Specifically,***
17897 21 CFR 212.71(b) 1 Investigation of nonconforming product You did not [completely] document the investigation of a PET drug product that did not meet specifications. Specifically,***
17898 21 CFR 212.71(c) 1 Correction of problems You did not take [appropriate] action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.  Specifically,***
17904 21 CFR 212.80(d) 1 Labeling and product mix-ups Labeling and packaging operations for PET drug products were not controlled to prevent labeling and product mix-ups.  Specifically,***
17913 21 CFR 212.100(a) 1 Written complaint procedures You have not [developed] [followed] written procedures for the receipt and handling of all complaints concerning the quality or purity of, or possible adverse reactions to, a PET drug product.  Specifically,***
17927 21 CFR 212.110(b) 1 Record quality All records including those not stored at your inspected establishment are not [legible]  [stored to prevent deterioration or loss] [readily available for review and copying by FDA employees].  Specifically,***
17937 21 CFR 212.70(e) 1 Notification to Facilities Re: Received PET Drug Sterility You did not notify all facilities that received a PET drug product that failed to meet a criterion for sterility of the findings from your investigation. Specifically***
17939 21 CFR 212.71(a) 1 Procedures to Investigate Cause of Non-Conforming Product You did not [establish] [follow] procedures to investigate the cause(s) of the nonconforming batch(s) of a PET drug product. Specifically, ***
17941 21 CFR 212.71(b) 1 Documentation of Non-Conforming Product Investigation You did not document [the results of the investigation] [what happened to the rejected PET drug product] for a PET drug product that did not meet specifications.  Specifically***

原文链接:http://www.fda.gov/iceci/enforcementactions/ucm381526.htm#drugs

IVIVR和IVIVC

IVIVR versus IVIVC
James E. Polli, Ph.D.
University of Maryland School of Pharmacy, Baltimore MD

It is natural to try to relate in vitro dissolution data to in vivo pharmacokinetic data. An effort to connect dissolution and pharmacokinetic results is often referred to as “in vitro-in vivo correlation” (IVIVC) analysis. Over the last 40 years, three often-used approaches to perform IVIVC are the so-called Level A, Level B, and Level C approaches (1). Among these three, Level A is generally viewed as the best method, since Level A utilizes all dissolution and pharmacokinetic data. Level B also utilizes all dissolution and pharmacokinetic data, but arguably is less insightful and helpful.

Level A IVIVC and its Failure for Immediate Release
For Level A analysis, the fraction drug absorbed (Fa) is plotted against the fraction drug dissolved (Fd). The fraction drug absorbed profile is obtained by deconvoluting the plasma profile. Deconvolution is essentially a back calculation to answer the question: “What must the drug absorption profile have been, given the plasma profile?” Of course, deconvolution requires some assumptions. The often sought out Level A profile is a
one-to-one relationship between absorption and dissolution, with slope equal to one and y-intercept of zero. Figure 1 presents a practically ideal Level A result.

Figure 1. Fa versus Fd profile for diltiazem HCl ER capsules.
Release is rate-limiting, resulting in a linear profile
(i.e. Level A IVIVC).

So why has the relationship in Figure 1 been a Holy Grail over the last 30 years? The simple answer lies in the fact that alternative methods are more difficult, and were practically unavailable 30 years ago. Level A analysis requires linear regression of Fa against Fd. Linear regression was (and still can be) easily performed by hand. The first commercially available computers provided linear regression software. Hence, given its advantages over Level B and Level C, along with the computational availability to perform linear regression, Level A analysis had become the preferred method to relate in vitro dissolution to in vivo pharmacokinetics.

A statistic from Level A analysis is r, the correlation coefficient. Its square, r2, ranges from zero to one and is a measure of the strength of relationship between Fa against Fd. Often, results with sufficiently large r2 (e.g. greater than 0.9) yielded “a (successful) correlation.” An r2 value that was too low resulted in a “no correlation” conclusion.

From this type of analysis, the term in vitro-in vivo correlation (IVIVC) evolved. Numerous IVIVC studies are in the literature. Controlled release products, rather than immediate release products, are the focuses in the IVIVC literature. Similarly, compendial and regulatory guidance (1,2) has been provided for controlled release products. IVIVC analysis for controlled release products is well accepted. Notable is that IVIVC analysis for immediate release products have been less successful (1). This disappointment with immediate release products has perhaps resulted in a generally low expectation for IVIVC success for immediate release products, including the questioning of the appropriateness of subjecting immediate release products to IVIVC.

A reason for this lack of success and acceptance may be the general failure of the Level A method to immediate release products. As noted above, Level A has traditionally been the most common IVIVC approach and requires a linear(ized) relationship between fraction drug absorbed and fraction drug dissolved.

However, this reason to reject IVIVC analysis for immediate release products is poorly founded. Since only products with dissolution rate-limited absorption (and with complete absorption) can be expected to exhibit a Level A plot with a slope of one and zero intercept (3), immediate release products will “fail” the Level A method, as generally is the case (1). Only products with significantly dissolution rate-limited absorption (and essentially complete absorption) will exhibit an IVIVC plot that fits the Level A description [e.g. Fig. 1] (3).

The intrinsic inability of immediate release products to conform to a Level A “straight line” appearance does not indicate that dissolution from such products fails as a surrogate for bioavailability. Also, the “failure” of immediate release products to exhibit dissolution rate-limited absorption should not infer that immediate release products are inappropriate candidates for other more relevant forms of IVIVC analysis (i.e. non-linear forms of IVIVC). Of course, the relevance of a dissolution test needs to be defendable in terms of the mechanism of drug release from the dosage form, including the role of physicochemical and physiologic factors (4).

The Slippery Slope of “Correlation”
So what are more relevant forms of IVIVC, that may apply to immediate release (IR)? Since dissolution is perhaps not rate-limiting in an IR product, the Fa against Fd profile will be non-linear. Figure 2 plots the Fa versus Fd profile for an IR product. Points in the profile do not follow the line of unity (i.e. Level A profile), but rather well below it, since absorption cannot “keep up” with dissolution.

Figure 2. Fa versus Fd profile for enalapril maleate tablets. Dissolution is more rapid than overall absorption, resulting in a non-linear profile.

Why might we feel uncomfortable with such a plot? Some dissatisfaction may arise from our expectation of an IVIVC. In IVIVC, “C” denotes “correlation”, which is defined as “the degree of relationship between two variables” (5). Correlation deals with the “tightness” in how two variables vary together. This term does not limit a relationship to only the linear type, but allows for non-linear relationships as well.

However, the most simple relationship (and thus the most appropriate to consider first) is the linear relationship. When one speaks of correlation, a linear relationship is immediately considered and inspected for. In practice, correlation is often taken to imply a linear relationship. For IR products, this limitation is problematic. Arguably, avoidance of the word “correlation” and the use of a more general term that would allow for non-linear relationships may aid in the development of IVIVC-type analysis of IR products.

IVIVR
One possible substitution for IVIVC is IVIVR, with “R” denoting “relationship.” By comparison with Level A IVIVC, IVIVR analysis would concern the
elucidation of the in vitro dissolution – in vivo absorption relationship. Hence, IVIVR need not be limited to straight-line relationships, which appear to be generally incorrect for IR products (1,6,7). One intent of IVIVR should be to learn about the relative contribution of dissolution to a product’s overall absorption kinetics.
One model for IVIVR is (3):

eq 1

where
F
a is the fraction of the total amount of drug absorbed at time t,
f
a is the fraction of the dose absorbed at t = #,
a is the ratio of the apparent first-order permeation rate constant (kpaap) to the first-order dissolution rate constant (kd), and
Fd is the fraction of drug dose dissolved at time t.

Of note is that the Level A method is a special (linear) case of eq 1. If fa = 1.0 (i.e. complete absorption) and a>>1# (i.e. strongly dissolution rate-limited absorption), then Fa = Fd, as in Fig 1.

This IVIVR analysis has been applied to several formulations of metoprolol, piroxicam, and ranitidine (6,7). IVIVR analysis indicated that formulation properties and drug substance biopharmaceutic properties influenced the degree to which dissolution controlled overall absorption kinetics. Interestingly, dissolution was not rate-limiting from even the slowest dissolving IR formulations for the high solubility drugs.

Future Directions
The use of the term IVIVR rather than IVIVC is preferred. Immediate release products are amenable to dissolution-absorption analysis. However, the term IVIVR itself is neither new (8), nor fundamental. Rather, what is needed is a better understanding of in vivo dissolution, and its in vitro surrogate, the dissolution test. Additionally, dissolution needs to be considered in the context of other parallel and sequential processes (e.g. permeability, degradation, and transit). Through a better understanding of dissolution, dissolution and IVIVR can facilitate not only SUPAC-type changes, but also facilitate drug product development.

References
1. USP 23-NF 18; United States Pharmacopeial Convention, Inc., Rockville, MD, 1994.
2. Extended Release Solid Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations, Center for Drug Evaluation and Research, Food and Drug Administration, September, 1997.
3. J.E. Polli, J.R. Crison, and G.L. Amidon, Novel approach to the analysis of in vitro-in vivo relationships, J. Pharm. Sci. 85, 753-760 (1996).
4. E. Galia, E. Nicolaides, D. Horter, R. Lobenberg, C. Reppas, and Dressman JB, Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm Res. 15, 698-705 (1998).
5. Kachigan, S.K. Multivariate Statistical Analysis; Radius Press, New York, 1991.
6. J.E. Polli, G.S. Rekhi, L.L. Augsburger, and V.P. Shah, Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets, J. Pharm. Sci. 86, 690-700 (1997).
7. J.E. Polli and M.J. Ginski, Human drug absorption kinetics and comparison to Caco-2 monolayer permeabilities, Pharm. Res. 15, 47-52 (1998).
8. J. Devane and J. Butler. The impact of in vitro-in vivo relationships on product development, Pharm. Tech. 21,146-159 (1997).

————————分割线————————————

原文地址:http://www.dissolutiontech.com/DTresour/800Articles/800_art1.html

2013年全国药企新药注册申报TOP100

两只小鸡

(旁白:图片很喜欢,上面的广告请忽略。。。)

开头这两家夫妻店真是牛逼啊(第8也是豪森的)。前十里面,3、5、7、8、10听都没听过。百度了一下:貌似以搞研发为主的。

南京华威医药科技开发有限公司(华威医药)成立于2000年,专业从事新药发现、研究、注册及临床CRO业务。

石药集团中奇制药技术(石家庄)有限公司好像就是石药集团药物研究院。

合肥信风科技有限公司成立于2000年,是专业从事新药研究的高科技企业,包括创新药研发、仿制药研发、合同外包业务。

江苏豪森医药集团连云港宏创医药有限公司……都是他上头豪森的信息。。。

南京海纳医药科技有限公司创立于2001年,能够高效质优地完成药物合成、制剂、分析、药理、注册、中试放大和大生产等药品研发过程。

序号 企业名称        申请注册数
1 江苏恒瑞医药股份有限公司 98
2 江苏豪森药业股份有限公司 52
3 南京华威医药科技开发有限公司 52
4 齐鲁制药有限公司 49
5 石药集团中奇制药技术(石家庄)有限公司 35
6 浙江海正药业股份有限公司 29
7 合肥信风科技开发有限公司 29
8 江苏豪森医药集团连云港宏创医药有限公司 27
9 山东罗欣药业股份有限公司 25
10 南京海纳医药科技有限公司 25
11 江苏正大天晴药业股份有限公司 24
12 济南康和医药科技有限公司 21
13 山东新时代药业有限公司 21
14 济南百诺医药科技开发有限公司 21
15 连云港润众制药有限公司 20
16 浙江华海药业股份有限公司 20
17 北京阳光诺和药物研究有限公司 20
18 山东创新药物研发有限公司 18
19 通化东宝药业股份有限公司 18
20 宜昌长江药业有限公司 17
21 成都倍特药业有限公司 16
22 山东京卫制药有限公司 16
23 宜昌人福药业有限责任公司 15
24 江西施美制药有限公司 15
25 江苏奥赛康药业股份有限公司 15
26 四川百利药业有限责任公司 14
27 浙江金华康恩贝生物制药有限公司 13
28 天津药物研究院 13
29 北京万生药业有限责任公司 13
30 北京韩美药品有限公司 13
31 山东裕欣药业有限公司 13
32 天津市汉康医药生物技术有限公司 13
33 南京柯菲平盛辉制药有限公司 13
34 广州艾格生物科技有限公司 12
35 浙江九洲药业股份有限公司 12
36 江苏先声药业有限公司 12
37 江西青峰药业有限公司 12
38 山东绿叶制药有限公司 12
39 安徽安科恒益药业有限公司 12
40 合肥合源药业有限公司 12
41 北京华素制药股份有限公司 11
42 石家庄四药有限公司 11
43 兆科药业(合肥)有限公司 11
44 齐鲁安替(临邑)制药有限公司 11
45 重庆华邦胜凯制药有限公司 10
46 四川科伦药业股份有限公司 10
47 四川科伦药物研究院有限公司 10
48 西安新通药物研究有限公司 10
49 江苏济川制药有限公司 10
50 北京福瑞康正医药技术研究所 9
51 重庆医药工业研究院有限责任公司 9
52 南京正大天晴制药有限公司 9
53 珠海联邦制药股份有限公司 9
54 南京先声东元制药有限公司 9
55 北京天坛生物制品股份有限公司 9
56 成都苑东药业有限公司 8
57 武汉药谷生物工程有限公司 8
58 江苏恩华药业股份有限公司 8
59 石家庄创建医药科技有限公司 8
60 深圳致君制药有限公司 8
61 山东轩竹医药科技有限公司 8
62 辽宁亿灵科创生物医药科技有限公司 8
63 齐鲁制药(海南)有限公司 8
64 河南天方药业股份有限公司 8
65 悦康药业集团有限公司 8
66 湖南明瑞制药有限公司 8
67 北京科莱博医药开发有限责任公司 8
68 南京艾德凯腾生物医药有限责任公司 8
69 中国中医科学院中药研究所 8
70 湖南方盛制药股份有限公司 8
71 南京优科制药有限公司 8
72 合肥拓锐生物科技有限公司 7
73 浙江医药股份有限公司新昌制药厂 7
74 内蒙古白医制药股份有限公司 7
75 山西普德药业股份有限公司 7
76 中国人民解放军军事医学科学院毒物药物研究所 7
77 山东鲁抗医药股份有限公司 7
78 合肥科大生物技术有限公司 7
79 珠海联邦制药股份有限公司中山分公司 7
80 陕西步长制药有限公司 7
81 石药集团欧意药业有限公司 7
82 海南美兰史克制药有限公司 7
83 北京悦康凯悦制药有限公司 7
84 深圳万乐药业有限公司 6
85 北京博时安泰科技发展有限公司 6
86 河南福森药业有限公司 6
87 浙江京新药业股份有限公司 6
88 华兰生物工程重庆有限公司 6
89 科贝源(北京)生物医药科技有限公司 6
90 重庆莱美药业股份有限公司 6
91 瑞阳制药有限公司 6
92 江苏万特制药有限公司 6
93 山东方明药业集团股份有限公司 6
94 北京润德康医药技术有限公司 6
95 安徽省新星药物开发有限责任公司 6
96 广东东阳光药业有限公司 6
97 辰欣药业股份有限公司 6
98 四川科泽药物研究有限公司 6
99 北京德众万全药物技术开发有限公司 6
100 江苏万邦生化医药股份有限公司 6

深圳东阳光2013年校园招聘会之沈阳药科大学站

时间是20121026日下午6点,地点为新四教室。来招聘的是深圳东阳光药业公司的研发部。主持人就是研发部的院长。演讲风格跟以往见过的招聘会、宣讲会都很不一样,听风趣的,也让人感觉很实在,现场不时会发出一阵笑声。(深圳来的这几家公司都挺有特色的。)

我是第一次从来开招聘会的主持人嘴里听到大胆签约,勇敢毁约口号的,快结束的时候还重复强调了一下。并建议大家去公司看了之后再签约,不要一时激动被骗过去了。公司给报销单程卧铺票,返程自己付,在那里想呆多久就呆多久,不回来更好。有人说坐高铁呢?主持人说这个以前没考虑到,以前没这个问题的,新时期有新问题了,也报销吧。主持人说坐飞机也给报销,停顿了一下,接着说,不过只报销火车卧铺的那个价格。

说他们研发部是国内最大的科研团队。

环境很好,有个大游泳池。

对于毁约,公司不会收取违约金。主持人的解释是本科生即将毕业的时候本来就没多少钱了,还要因为毁约支付几千块钱,心里会恨死公司的。为了几万块的违约金,把名声弄臭了可不值得,公司又不缺这点钱。

深圳东阳光是做铝业起家的,铝业做得很好。以铝业的实体领域支持药业和南岭养生两大领域。比较有保障。

院长东阳光药本来计划今年上市,但是今年行情不好,以后再上市。

公司的实验设备很好,说了几个设备的数量,然后又问我们学校有几个,有些设备比我们学校多一点,有些比我们学校少一点。数据库我们学校有6个(也可能是9个),他们有十几个数据库。

他们研发部的那些主干人员(海归教授之类的)都挺厉害的,年薪超过百万。院长说实力上不比沈药差,博士什么的去那里也能学到东西。

这次东阳光招人很多(不是都在沈药招,还有其他城市其他学校,不过我猜药学方面的主要应该是在沈药招,因为我看他们校园招聘会行程上的校园名单为吉林大学、兰州大学、南开大学、复旦大学、沈阳药科大学、湖南工业大学、四川大学、北京化工大学和天津大学,不知道是不是忘了写了,反正上面没写中国药科大学和广东药学院)。

具体招聘人数为:博士41人、硕士235人、本科175人、专科1人(这个专科1人很醒目啊)。

招聘职位:临床监查员、合成研究员、制剂研究员、分析研究员、药理研究员、生物药研究员、专利工程师、注册专员、新能源研究员、新材料研究员、铝业研究员、IT工程师等。

专业要求:医学、有机合成、药物化学、药剂、药理、药学、毒理学、制药工程、食用菌栽培、生物技术、昆虫饲养、知识产权、分子生物学、包装工程、设计、材料、冶金机械类、电子及IT等相关专业。

HEC的含义:Hopeful Energetic Co.(充满希望,有激情的公司,说实话看到这几个英文单词时我的第一反应是想到了美国的谷歌公司和谷歌公司著名的餐厅。)

公司提供学位补贴:普通本科是100,211本科是120,硕士是300左右,博士是400左右。以上为第一年的补贴,每过一年补助翻一番,如普通本科第二年的补助是200,其余类推。补到10年为上限,还是以普通本科为例,当补助增加到1000时就不再增加补助了。关于沈药属于哪个范畴,主持人说了,沈药按照211来算。

刚招过去的新生需要在3个月内记住所在部门要求记住的一千个专业词汇,记不住的话就不能转正。

相关福利及待遇:

1、落户深圳。(东阳光药公司在东莞,占地两百亩,落户则是在深圳。英语没过四级的不能落户深圳。)

2、年薪:本科4.5-5.5万,硕士7.5-8.5万,博士13-15万。

3、提供单间住房,每平米收取物业管理费3元,结婚可提供单元房一套。(这是网上他们的说明,宣讲会现场的PPT上说是本科男生为三人合租30平米,免费。本科女生和男女硕士生住宿都是要一点钱的,不多,差不多一两百吧,主要的钱都是公司出的。没注意记,但是住的地方比较好。公司会建职工宿舍,但是宿舍数量不够,以后宿舍建够了会同意住在职工宿舍的。公司对中级及以上的员工直接提供三星级住房,院长说那个三星级的质量比沈药附近的锦江之星要好。)

4、社会统筹保险按国家有关规定办理。(五险一金的事情没提,网上有人说只提供五险不提供一金,真假不知。)

———————————————————————————————————————————————

华丽分割线

———————————————————————————————————————————————

以下内容更新于:20121027日。

今天早上看到了手机上的面试短信,叫我上午1020去沈药西侧锦江之星酒店三楼会议室面试。

面试时是大家都坐在房间里的座位上(有点类似于教室,前面居然还有块写字板),然后面试官(我们的面试官是研究院的院长)一个一个逐次的问一些很简单的问题,就是确认一下我们的名字、爱好、住所,研究生还会问一下研究方向。平均一个人就一两分钟时间,没见过这么快的面试速度。面试的时候面试官一直断断续续的在接电话(感觉这样子有点不好吧,好像不尊重我们一样)。

后来听同学说他学姐跟他说了,这个公司虽然每年在校园招聘会上写着招这么多,但是去年在沈药只招了5个人,包括2个博士在内。

希望不要打酱油啊。

深圳信立泰2013年校园招聘会之沈阳药科大学站

深圳信立泰2013年校园招聘会在1016日下午6点于沈阳药科大学图书馆四阶正式开始。   上台讲话的一共有两个人,一个是主持人,还有一个是什么研发部经理,不记得叫什么了,只知道姓陈,因为主持人一直唤经理为陈伯。主持人讲话给人的亲和力很强,尤其是微笑的时候,让人觉得就是一位大姐姐。   这次宣讲会给人的感觉是很真实的。主持人说话也很实在。主动地跟我们说了本科生年薪是在四万到五万之间。介绍的时候也是有就说有,没有就说没有,不耍滑头。经理讲话也很实在,具体到某种药仍处于生产研究阶段,尚未在市场上销售都讲了出来。   深圳真的挺让人向往的,无论是上次华润三九的招聘会还是这次深圳信立泰的招聘会都让人感觉到了一股比较有活力的氛围。尤其是跟上次扬子江药业招聘会的那种过分保守相比之下,给人的心理对比是比较大的。   信立泰发了一张评估表、一张性格测试题和一张性格测试答题卡。简历要求是评估表下附自己事先带过来的简历,再在下面附上性格测试题的答题卡。   性格测试题要求收回上交(低碳环保啊,一般的企业估计就不管了)。   对了,主持人说了深圳信立泰的企业精神是:美好源于诚信。难怪招聘会听起来如此实实在在。   这次招聘会没有跟医药代表或者销售相关的职位。跟药学相关的主要就是生产,研发和质量控制等。招收的人数从1个到十几个不等,有人问了这个数字是对所有招聘会而言的,还是在沈药就招那么多人,主持人说是就所有举行信立泰校园招聘会的高校而言的,但是沈药的会优先考虑,至于真假就不好说了,但是我们学校在同行里还算是比较强的,于情于理都符合常理。   招聘会上说第二天上午八点之前会短信通知,所以我晚上手机一直保持着开机状态。笔试的短信通知大概是在早上7点左右发过来的。   由于昨天招聘会的时候已经做过性格测试了,一直担心上午的笔试会考什么内容,结果是碰到的考试内容有两份。   一份是快速找出各个选项中相同字符的个数,卷子上写着要求是10分钟完成,一共35道题左右吧。要把答案图在答题卡上,所以最好带上铅笔,这样涂错了可以改,不过大家都是用黑色水笔的,所以问题也不大,只是不好改了。   另外一份卷子一共有四道题,第一道是问你做过什么让你印象深刻的实验项目,实验用到了什么知识和原理,以及你从中得到了什么启发。第二道题是一道合成题,用间硝基甲苯合成苯甲酰间甲基苯胺。第三题是如何确定一个化合物是否为纯化合物。第四题是对一段给出的英文实验过程进行翻译,化合物名称可以不翻译直接使用英文。   考试时间大概有五十分钟左右,到时间把所有答卷一起上交。所以第一张找相同字符的卷子做起来时间是很充足了,花半个小时做都行,不过没必要,因为确实很简单。   忘了说了,以上是对应聘工艺技术员岗位的人而言的。笔试的时候坐在我左边的女生和坐在我右边的男生都是硕士,那个女生的卷子都和我的一样,那个男生的卷子比我们要多了一份,具体内容没看,反正看他画了个不知道什么图谱,好像做图谱分析遇到的图一样。我想我们之所以答题时间那么宽裕多半是因为他们有些人要回答的题目比我们多吧。   有些岗位是当天下午就安排了面试。有些岗位是之后电话面试,面试时间在11月到12月之间。战线拉得很长啊。   公司提供五险一金。公司提供住宿,但是每月需要交三百块钱。公司提供三餐伙食,不需要掏钱。福利整体来说还是不错的。

深圳海王2013年校园招聘会之沈阳药科大学站

几天前的事情了,没及时写下来,估计很多东西回忆不起来了。
来的hr是个美女,很年轻,还没结婚,在学校学的是类似于哲学之类的专业。宣讲会上经常提到深圳去香港很方便,同样的东西在香港会比在大陆便宜好多,深圳是个包容的城市,与北京更需要你有个好关系好背景不同,深圳更需要能力,有能力就能在深圳发展下去。还跟我们说到了深圳不要跟当地人比,要比得跟同年龄段的同事什么的比。因为深圳本地人他们不用怎么赚钱就有钱了,他们把地让政府租给企业,每年拿分红就有好多钱了,他们天天开个小店铺,穿双拖鞋打麻将。看得出来这个主持人真的是学类似于哲学之类的专业的,喜欢说教,说得的确不错,很实际,不是空谈。一般企业是不会在宣讲会上进行人生观教育的。
现场有三次抢答机会,送出了三份深海鱼油。
投研发类岗位的硕士博士不需要参加笔试,宣讲会结束后直接可以走,需要把简历网投给深圳海王公司,由那边的相关经理(好像是经理,不记得了)直接筛选。选中的人参加一个简单的面试就行了,主持人说这个面试没有难度,只要沟通没有障碍就行。投qa,qc,生产工艺员和储备干部的全部在宣讲会结束后直接留下来参加笔试。笔试分三套题,投qaqc的做的是考察药物分析专业知识的题目,投生产工艺员的人做的是考察药物制剂专业知识的题目,投储备干部的那批人考什么内容我不清楚。最后答完卷子后把卷子和自己带的简历一起交上去。回去之后最好再进行一下网投。宣讲会之后的第三天就会签协议。薪资方面主持人没透漏,只是说属于中上水平,我觉得主持人说得是实话。公司只包午餐,另外两餐自费。员工宿舍是四人寝室。主持人说他们公司有黄埔军校的称号,看来也是真的。同学有接到电话面试的,也有接到短信要现场面试的。从反馈消息来看,海王的生产工艺员经常会加班,经常是要干12个小时,而且双休日也可能要加班。公司提供五险一金。而且主持人给我们补了一个知识漏洞:如果户口不在深圳的只能办四险一金,生育险是没法办的。公司能提供落户深圳,主持人给我们的意见是:如果你是农村户口自己有地的建议不要把户口迁到深圳,如果是二三线小城市的城市户口则可以把户口搬到深圳。从笔试现场看,投生产工艺员的主要是男生,只有两个女生。投qa,qc的则主要的女生。储备干部男女都有投递。

药企地址及官网链接

提示:如果想查看某个省份的药企,可以按键盘上的“Ctrl+F”快捷键,然后输入你想查看的省份名称进行查看。点击药企名称所带链接会直接在新的窗口打开指定药企官网,您可在官网上阅读最新信息。

  1. 江苏恒瑞医药股份有限公司:江苏省连云港市经济技术开发区昆仑山路7号。(相当不错的药企,加之连云港环境也不错!)
  2. 江苏豪森药业股份有限公司:江苏省连云港市。(和恒瑞是夫妻店。)
  3. 康缘药业:江苏省连云港市。
  4. 江苏正大天晴药业股份有限公司:江苏省连云港市。
  5. 深圳致君制药有限公司:广东省深圳市宝安区观澜高新技术产业园官宝路16号。
  6. 浙江仙居君业药业有限公司:浙江省台州市仙居县君业路1号。
  7. 浙江天台药业有限公司:浙江台州天台县丰泽路588号。
  8. 浙江海正药业:浙江省台州市椒江区外沙路46号。
  9. 海正药业(杭州)有限公司:浙江省杭州市富阳市胥口镇下练村。(浙江海正药业股份有限公司的全资子公司。)
  10. 海南海药股份有限公司:海南省海口市秀英区海药工业园(南海大道西66)
  11. 海南华益泰康药业有限公司:海南省海口市南海大道
  12. 沈阳兴齐眼药股份有限公司:沈阳经济技术开发区三号街124号。
  13. 武汉恒信源药业有限公司:武汉市东湖高新技术开发区光谷生物城九龙生物医药园。
  14. 亚宝药业集团股份有限公司:山西省风陵渡经济开发区工业大道1号。(亚宝药业太原制药有限公司办公地点。)
  15. 赛诺菲中国:上海市南京西路1266号恒隆广场办公楼1号楼31-32层。
  16. 北京凯德思达医药生物技术有限公司:北京市丰台区南四环西路188号总部基地522幢。
  17. 江苏新晨医药有限公司:江苏省连云港市经济开发区昆仑山路7号。
  18. 悦康药业集团有限公司:北京市经济技术开发区宏达中路六号。
  19. 济南百诺医药科技开发有限公司:济南市山大路11号。
  20. 湖南赛隆药业有限公司:湖南岳阳华容工业园(没找到官网地址!)
  21. 滇虹药业集团股份有限公司:昆明国家高新技术产业开发区科医路45号。
  22. 重庆药友制药有限责任公司:重庆市渝北区人和镇(北部新区高新园区)星光大道 100号。
  23. 河北智同医药控股集团有限公司:河北省石家庄市高新技术开发区泰山街219号。
  24. 曼秀雷敦:??
  25. 石家庄以岭药业股份有限公司:河北省石家庄市天山大街238号。
  26. 山东罗欣:山东临沂国家高新技术产业开发区罗七路。
  27. 深圳市瑞霖医药有限公司:深圳市南山区高新区高新中一道万和医药园1-3F
  28. 中国大冢制药有限公司:天津市西青区精武镇津文公路西。
  29. 上海和黃药业有限公司:上海市九江路399号华盛大厦13楼。(网站底部一堆六合彩、开奖之类乱七八糟的外链很损形象啊!)
  30. 迪沙药业集团有限公司:山东省威海市经济技术开发区青岛南路1号。
  31. 昆泰医药发展有限公司:暂时找不到官网地址!
  32. 成都康弘药业:四川省成都市蜀西路36号。
  33. 东北制药集团销售有限公司:辽宁省沈阳市铁西区兴华南街56 东药物流。
  34. 长春迪瑞医疗科技股份有限公司:长春市高新技术产业开发区云河街95号。
  35. 宁波药腾国际贸易有限公司:暂未找到官网和地址。
  36. 中化宁波:浙江宁波(具体不知!)
  37. 南京正大天晴制药有限公司:南京市长江路188号德基大厦22层。
  38. 江苏正大天晴药业股份有限公司:江苏省连云港市新浦区巨龙北路8号(连云港的一个通讯地址!)
  39. 沈阳沃顿生物技术有限公司:辽宁省沈阳市和平区三好街87号五里河城7层。
  40. 辅仁药业集团医药有限公司:河南省郑州市金水区红专路63号辅仁大厦。
  41. 天津天士力
  42. 云南白药
  43. 南京圣和药业
  44.  天津华津制药
  45.  辽宁天下金控投资集团股份有限公司
  46.  汉典集团
  47.  上海信谊
  48.  丽珠医药集团
  49. 江苏恩华药业股份有限公司
  50.  康龙化成
  51.  人福医药
  52.  烟台万润
  53.  广东天普生化医药
  54.  联邦制药(珠海中山)有限公司
  55.  宁波朗生医药
  56.  黄海制药
  57.  浙江爱生药业有限公司
  58.  诺华制药
  59.  广州白云山中一药业
  60.  先声药业
  61. 天津美伦医药集团
  62.  江苏恒瑞医药股份有限公司
  63.  石药集团
  64.  开原亨泰制药股份有限公司
  65.  晨光生物科技集团股份有限公司
  66.  大连辉瑞
  67.  药明康德
  68.  卓越和发
  69.  施维雅
  70.  上海复星医药
  71.  北京国立柏林医学科技发展有限公司
  72.  深圳市东阳光实业发展有限公司
  73.  沈阳三九药业
  74. 绿叶制药集团
  75.  江苏恒瑞医药销售有限公司
  76.  北京泰德制药股份有限公司
  77.  国药集团
  78.  华瑞制药
  79.  默沙东
  80.  精鼎医药研究开发(上海)有限公司
  81.  青松华药
  82.  保诺科技
  83.  埃森哲信息技术有限公司
  84.  葛兰素史克公司
  85.  深圳海王
  86.  高知特信息技术(上海)有限公司
  87.  重庆圣华曦药业股份有限公司
  88.  联邦制药(成都)有限公司
  89.  新和成集团北京万生药业
  90.  拜耳医药
  91.  深圳信立泰
  92.  北京费森尤斯卡比医药
  93.  扬子江药业
  94.  海思科药业
  95.  沈阳中普生物制品有限公司
  96.  华润三九
  97.  中国远大
  98.  力诺药业(济南永宁制药)
  99. 强生医疗
  100.  礼来
  101. 罗氏制药
  102. 鞍山市齐敏整形美容医院:辽宁省鞍山市铁东区体育巷。
  103.  保定九孚生化有限公司:河北省保定市满城于家庄工业区。
  104.  北京柏雅联合药物研究所有限公司:北京市丰台区富丰路4号工商联大厦A-1006
  105.  北京北大维信生物科技有限公司:北京市海淀区海淀南路30号航天精密大厦7层。
  106.  北京北大维信生物科技有限公司辽宁分公司:沈阳市铁西区爱工北街11-4罗马假日B1-14-3
  107.  北京博爱旺康医药科技有限公司:北京市大兴区北京经济技术开发区中和街22号。
  108. 北京阜康仁生物制药科技有限公司:北京丰台路4号工商联大厦1604A
  109.  北京国立柏林医学科技发展有限公司:北京朝阳区黄寺大街甲三号金色梧桐商务中心三层
  110.  北京哈三联科技股份有限公司:北京市昌平区超前路37号中关村兴业创业园4号楼4层。
  111.  北京海步国际医药科技发展有限公司:北京经济技术开发区宏达北路12B1309
  112.  北京韩美药品有限公司:北京市顺义区天竺空港工业区A区天柱西路十号。
  113.  北京汉典集团:北京市朝阳区朝外九街乙121号楼昆泰园际大厦2206
  114.  北京汉典制药有限公司:北京市朝阳区朝外大街乙121号楼昆泰国际大厦2210
  115. 北京红太阳药业有限股份有限公司:北京市朝阳区朝外大街乙121号楼
  116.  北京京丰制药有限公司:北京市丰台区科学城航丰路8
  117. 北京九州通医药有限公司:北京市大兴区大兴经济开发区广平大街9
  118. 北京凯德思达医药生物技术有限公司:北京市丰台区西四环南路188号五区22
  119. 北京凯恩科技股份有限公司北京市经济技术开发区荣荣东街6
  120.  北京科信必成医药科技发展有限公司哈尔滨分公司:哈尔滨市先锋路469号双太电子产业信息园13#东侧三楼
  121.  北京朗依制药有限公司:北京市朝阳区管庄乡双桥路559
  122.  北京利祥制药有限公司:北京市顺义区林和工业开发区顺康路64
  123. 北京诺泓医药科技有限公司:北京大兴生物医药产业基地永兴路25号北京好景象科技园
  124. 北京赛升药业股份有限公司:北京经济技术开发区兴盛街8
  125. 北京石草溪医药技术有限公司:北京经济技术开发区科创六街88
  126. 北京世桥生物制药有限公司:北京市顺义区北石槽真中北工业园
  127. 北京市燕京药业有限公司:北京市朝阳区管庄杨闸路环岛1
  128. 北京四环制药药物研究院有限公司:北京市石景山区古城西街33号富诺生物创新基地A3
  129. 北京泰德制药股份有限公司:北京经济技术开发区荣京东街8
  130. 北京沃华瑞通科技有限公司:北京市海淀区永泰庄路甲532号楼529
  131. 北京祥瑞生物制品有限公司:北京市怀柔区雁栖开发区雁栖北三街17
  132. 北京新领先医药科技发展有限公司:北京市海淀区清华东路16号艺海大厦1403
  133. 北京亚东生物制药有限公司:北京市北四环中路海泰大厦1511
  134. 北京昭衍新药研究中心有限公司:北京经济技术开发区荣京东街甲5
  135. 本溪恒康制药有限公司:本溪市明山区高台子镇前场子村
  136. 本溪经济开发区康迈斯医药有限公司:本溪生物医药产业基地研发中心南区
  137. 本溪仙草堂药业有限公司:溪湖区石桥子香槐路14
  138. 成都华高药业有限公司:成都市高新区天府四街66号航行国际2号楼9
  139. 成都生物制品研究所有限责任公司:成都市锦江区锦华路三段379
  140. 承德颈复康药业集团有限公司:河北省承德市武烈路109
  141. 大连海王星辰医药有限公司:大连市沙河口区南沙街95
  142. 大连联华化学有限公司:大连市金州新区金滨路5
  143. 大连市皮肤病医院:大连市沙河口区长江路788
  144. 大连天山药业有限公司:大连市甘井子区营城子工业园区
  145. 丹东市人民医院:丹东市振兴区振八街8-18
  146. 迪沙药业集团有限公司:山东省威海市经区青岛南路1号迪沙药业有限公司
  147. 东北农业大学:黑龙江省哈尔滨市香坊区公滨路木材街59
  148. 东北制药(沈阳)科技发展有限公司:沈阳经济技术开发区昆明湖街8
  149. 东北制药集团销售有限公司:沈阳市铁西区兴华南街56
  150. 东软熙康健康科技有限公司:沈阳浑南新区
  151. 福建广生堂药业股份有限公司:福州市五四路158号环球广场A32
  152. 福润九州医疗器械有限公司:沈阳市太原南街132
  153. 福州海王金象中药制药有限公司:福建省福州市晋安区鼓山镇中下278
  154. 葛兰素史克
  155. 广东康臣药业有限公司:广州市经济技术开发区东区东鹏大道71
  156. 广东仙乐制药:广东省汕头市龙湖区泰山路83
  157. 广西壮族自治区中医药研究院:广西南宁市东葛路20-1
  158. 广州白云山光华制药股份有限公司:广州市海珠区南石路16
  159. 广州白云山潘高寿医药股份有限公司:广州市番禺区天保路11
  160. 广州白云山奇星药业有限公司:广州市赤岗北路33
  161. 广州白云山天心制药股份有限公司:广州市海珠区江东路808
  162. 广州白云山制药股份有限公司:广州白云山制药总厂广州市白云区同和街云祥路88
  163. 广州柏赛罗药业有四按公司:广州市花都区新华镇董秀一横路9
  164. 广州康瑞泰药业有限公司:广州市开发区开源大道11号广州科技企业加速器A75
  165. 广州王老吉药业股份有限公司:广州市白云区广花二路831
  166. 广州医药集团有限公司:广州市沙面北街45
  167. 广州医药有限公司:广州市荔湾区大同路97-103
  168. 桂林三金药业股份有限公司:广西桂林市金星路1
  169. 国药集团国瑞药业有限公司:辽宁省大连市沙河口区福佳新天地
  170. 国药集团药业股份有限公司:北京市东城区永外三元西巷甲12
  171. 国药控股沈阳有限公司:沈阳市苏家屯区雪莲南街158
  172. 国药控股天津有限公司:天津市和平区大连道1
  173. 哈尔滨誉衡药业股份有限公司:黑龙江省哈尔滨市利民开发区燕京路29
  174. 哈药集团三精制药股份有限公司:哈尔滨香坊区哈平路233
  175. 哈药集团生物工程有限公司:海尔滨是道里区群力大道4
  176. 哈药集团有限公司:海尔滨是道里区群力大道1
  177. 哈药集团制药六厂:海尔滨是道里区群力大道2
  178. 哈药集团中药有限公司:海尔滨是道里区群力大道3
  179. 海南碧凯药业邮箱公司:海口市金牛路9
  180. 海南海神药业集团股份有限公司:海南省海口市玉沙路5号国贸中心22
  181. 海南海药股份有限公司:海南省海口市秀英区南海大道西66
  182. 海南华益泰康药业有限公司:海南省海口市南海大道273号高新区D
  183. 海南通用三洋药业有限公司:海口市秀英区海力路8
  184. 海正药业(杭州)有限公司:浙江省富阳市胥口镇下练村
  185. 杭州九源基因工程有限公司:杭州经济技术开发区8号路23
  186. 河北恒祥医药集团扁鹊制药有限公司:河北省邢台市新华南路506
  187. 河北联合大学:河北唐山建设南路57
  188. 河北智同医药控股集团有限公司:
  189. 黑龙江威凯洱生物技术有限公司:黑龙江省哈尔滨市道里区建国北四道街123
  190. 湖南千金湘江药业股份有限公司:湖南省株洲市荷塘区文化路1
  191. 湖南塞隆药业有限公司:湖南省岳阳市华容工业园
  192. 华北制药集团有限责任公司:河北省石家庄市和平东路388
  193. 华东医药股份有限公司:杭州莫干山路866
  194. 华熙福瑞达生物医药有限公司:山东省济南市高新区天辰路678
  195. 惠州市晟荣生物科技有限公司:广东省惠州市大亚湾石化区联宏化工区
  196. 吉林敖东延边药业股份有限公司:吉林省敖化市敖东大街2158
  197. 吉林四长制药有限公司:吉林省梅河口市珠江路北段1666
  198. 济南百诺医药科技开发有限公司:济南市山大路11
  199. 江苏奥赛康药业股份有限公司:南京市江宁科学园科建路699
  200. 江苏晨牌药业有限公司:江苏省海门市人民中路172
  201. 江苏德源药业有限公司:连云港市经济技术开发区长江路29
  202. 江苏恩华药业股份有限公司:江苏省徐州市民主南路69号恩华大厦
  203. 江苏恩华药业股份有限公司(营销公司):江苏省徐州市民主南路69号恩华大厦1309
  204. 江苏豪森医药集团连云港宏创医药有限公司:江苏省连云港市大浦工业区开泰路8
  205. 江苏豪森医药集团有限公司:江苏省连云港市经济技术开发区东晋路9
  206. 江苏豪森医药销售有限公司:江苏省连云港市经济技术开发区花果山大道东晋路9
  207. 江苏恒瑞医药股份有限公司:江苏连云港经济开发区昆仑山路7
  208. 江苏恒瑞医药销售有限公司:江苏省连云港市国家级经济技术开发区昆仑山路7
  209. 江苏康缘药业股份有限公司:江苏省连云港市经济技术开发区江宁工业园
  210. 江苏南星药业有限责任公司:江苏省南京市新港开发区恒竞路29
  211. 江苏太平洋美诺克生物药业有限公司:浙江省常州市新北区河海西路128
  212. 江苏泰康生物医药有限公司:泰州市药城大道1号国家新药创制中心
  213. 江苏新晨医药有限公司:连云港市经济技术开发区昆仑山路7号恒瑞大楼709
  214. 江苏正大丰海制药有限公司:江苏省大丰市南翔西路266
  215. 江苏正大天晴药业股份有限公司:江苏省连云港市新浦区巨龙北路8
  216. 江西江中制药(集团)有限责任公司:江西省南昌市高新区火炬大街788
  217. 金凯美(大连)医药科技有限公司:大连高新园区双D港辽河东路9
  218. 锦州奥鸿药业有限责任公司:锦州市太和区福州街10
  219. 开发区博美医药新技术开发有限公司:研发中心南区B
  220. 科锐国际人力资源(北京)有限公司:北京市朝阳区门外大街16号中国人寿大厦1301
  221. 科兴(大连)疫苗技术有限公司:大连经济技术开发区双D港生命二路36
  222. 昆明制药集团股份有限公司:昆明市五华区高新技术开发区科医路166
  223. 丽珠集团利民制药厂:广东省韶关市工业西路89
  224. 丽珠集团新北江制药股份有限公司:广东省清远市人民一路
  225. 连云港瑞邦药业有限公司:江苏省连云港市赣榆经济开发区通港大道
  226. 辽宁百凤手物药业有限公司:本溪市溪湖区石桥子春安街5
  227. 辽宁北药物流配送有限公司:沈阳市和平区胜利南街175
  228. 辽宁本源制药有限公司:辽宁省本溪市石桥子山城路12
  229. 辽宁博鳌生物制药有限公司:辽宁省本溪市石桥子经济开发区百合路1
  230. 辽宁大石药业有限公司:本溪生物医药产业开发区
  231. 辽宁富东制药有限公司:辽宁省本溪市药业产业园区溪湖区石桥子春安街9
  232. 辽宁好护士药业集团:本溪市溪湖区石桥子香槐路158
  233. 辽宁华润本溪三药有限公司:本溪高新技术开发区华润本溪三药人力资源部
  234. 辽宁九洲龙跃药业有限公司:本溪市溪湖区石桥子神农大街49
  235. 辽宁康普瑞医药有限公司:本溪经济技术开发区枫叶路208
  236. 辽宁科泰生物基因制药股份有限公司:本溪市经济开发区香槐路106
  237. 辽宁美联美容管理有限公司:沈阳市和平区文萃路8
  238. 辽宁诺维制药有限公司:本溪经济开发区香槐路61
  239. 辽宁琦润生物科技有限公司:本溪市经济技术开发区药都
  240. 辽宁省医药对外贸易公司:沈阳市大东区东北大马路146
  241. 辽宁天广仁合药业有限公司:沈阳市铁西区爱工北街18-41
  242. 辽宁天下金控股投资集团服份有限公司:沈阳市和平区三好街87号三好SOHO大厦4
  243. 辽宁修正生物制药有限公司:辽宁省本溪市溪湖区石桥子香樟路8
  244. 辽宁药联制药有限公司:本溪市高新区香槐路122A
  245. 辽宁伊利乳业有限责任公司:沈阳市辉山农业高新技术开发区宏业街73
  246. 辽宁依生生物制药有限公司:沈阳市沈北新区道义开发区
  247. 辽宁宇鹏医药有限公司:沈阳市大东区小东路241
  248. 辽宁中海康生物药业有限公司:辽宁省本溪市溪湖区石桥子华佗大街55
  249. 罗盖特(上海)有限公司:上海市淮海中路1010号嘉华中心501*505*604
  250. 南京威斯康国际贸易有限公司:南京市雨花台区花神大道21号德讯科技大厦1
  251. 南京正大天晴制药有限公司:南京市长江路188号德基大厦22
  252. 南阳医学高等专科学校:南阳市卧龙路1439
  253. 南阳医学院高等专科学校第一附属医院:南阳市卧龙路47
  254. 宁波药滕国际贸易有限公司:宁波市鄞州区日丽中路757号奥克斯中央大厦1101
  255. 宁波中药制药有限公司:宁波壮全区无宝山路525
  256. 宁夏康亚药业有限公司:银川市经济技术开发区6
  257. 盘锦市食品药品检验所:辽宁省盘锦市兴隆台区金城路73
  258. 普莱柯生物工程股份有限公司:洛阳市洛南新区政和路15
  259. 齐鲁制药(营销):山东省济南市工业北路243
  260. 青岛国风金百合医药销售有限责任公司(沈阳办事处):沈阳市和平区南八马路27号金辉食府A717
  261. 青岛上药国风医药有限公司:青岛市市南区山东路42号三层
  262. 荣港生技医药科技(北京)有限公司:上海市黄浦区西藏南路12082DE
  263. 瑞普(天津)生物药业有限公司:天津市东丽开发区六经路6
  264. 瑞阳制药有限公司:山东省沂源县二郎山路6
  265. 赛诺菲(杭州)制药有限公司:杭州市余杭塘路108
  266. 山东阿如拉药业有限公司:济南市高新区舜风路3221号楼5
  267. 山东方明药业集团股份有限公司:山东省东明县黄河路方明段
  268. 山东福瑞达医药集团公司:济南市高新区新区新泺大街989
  269. 山东国际生物科技园发展有限公司:山东省烟台市高新区科技大道39
  270. 山东亨利医药科技有限责任公司:济南市高新区舜华路750号大学科技园A302
  271. 山东鲁抗舍里乐药业有限公司:山东省济宁市太白楼西路173
  272. 山东鲁抗医药股份有限公司:山东省济宁市太白楼西路173
  273. 山东绿叶制药有限公司:山东省烟台市莱山区宝源路9
  274. 山东齐都药业有限公司:山东省淄博市临淄区人民东路28
  275. 山东省生物药物研究所:济南市新泺大街989
  276. 山东省潍坊市康华生物技术有限公司:山东省潍坊市月河路699
  277. 山东新华制药股份有限公司:山东省淄博高新区鲁泰大道1
  278. 山东新时代药业有限公司:山东省临沂市费县北环路1
  279. 山东轩竹医药科技有限公司:山东省济南市高新区天辰大街2518
  280. 山东淄博新达制药有限公司:山东淄博高新区鲁泰大道一甲一号新达制药
  281. 山西普德药业股份有限公司:山西省大同市经济技术开发区(湖东区)
  282. 山西仟源制药有限公司:大同市经济技术开发区湖滨大街53
  283. 山西远扬医药科技有限公司:山西省太原市高新区创业街29
  284. 陕西省食品药品检验所:西安市朱雀大街421
  285. 上海博锐生物科技有限公司:上海市徐汇区华径路130510B座六楼
  286. 上海迪赛诺药业有限公司:上海市浦东新区张衡路1439
  287. 上海恒瑞医药有限公司:上海市闵行区文井路279
  288. 上海唐星生物科技有限公司(沈阳分公司):沈阳市铁西区启工街建设中路第一城小区F1-28-4
  289. 上海威智医药科技有限公司:上海市松江区寅西路469
  290. 上海医药工业研究院:上海市北京西路
  291. 深圳立健药业有限公司:广东省深圳市龙华新区大浪街道同富裕工业园同富路
  292. 深圳万乐药业有限公司:深圳市福田区八卦四路万乐药业大厦
  293. 沈阳澳华制药有限公司:本溪经济开发区香槐路118
  294. 沈阳迪安医学检验所有限公司:沈阳市经济技术开发区沧海路35
  295. 沈阳粉红丝带健康管理有限公司:沈阳市铁西区卫工南街8-1
  296. 沈阳弗莱明医药科技有限公司:沈阳市和平区中山路2号医药大厦3035
  297. 沈阳光大制药有限公司:沈阳经济技术开发区松花湖街31
  298. 沈阳红旗制药有限公司:沈阳市浑南新区新络街6
  299. 沈阳红药制药股份有限公司:沈阳市大东区北大营西路2
  300. 沈阳金域医学检验所有限公司:沈阳市辉山农业高新区辉山大街123-22A
  301. 沈阳千年科技有限公司:沈阳市沈河区奉天街333号恒运商务大厦1504
  302. 沈阳三九药业有限公司:新民市车城街工业园
  303. 沈阳三生制药有限责任公司(生产研发):沈阳经济技术开发区十号路13
  304. 沈阳三生制药有限责任公司(销售):沈阳经济技术开发区十号路13
  305. 沈阳沈龙药业有限公司:沈阳市浑南新区金辉街9
  306. 沈阳松林科技有限公司:沈阳市沈河区先农坛路蓝星大厦15219
  307. 沈阳同联集团有限公司:沈阳市大东区东顺城街育才巷18
  308. 沈阳万类生物科技有限公司:沈阳市浑南新区新隆街10-1号生物医药园三楼
  309. 沈阳网药科技有限公司:沈阳市和平区市府大路168号华姿国际大厦1003
  310. 沈阳维隆动物药业有限公司:沈阳辉山农业高新区启农路28
  311. 沈阳沃顿生物技术有限公司:沈阳市和平区三好街三好SOHO大厦七层
  312. 沈阳仙凡之约母婴护理机构:和平区五里河街昌鑫大厦G2006
  313. 沈阳鑫慧聪科技有限公司:沈阳市沈河区神州路99号太和大厦A1803
  314. 沈阳兴齐眼药股份有限公司:沈阳市铁西区强工一街15
  315. 沈阳雅轩餐饮管理有限公司:沈阳市皇姑区黄河南大街85-3
  316. 沈阳药大药业有限责任公司:沈阳市沈河区文化路103
  317. 沈阳中海生物技术开发有限公司:沈阳市沈河区南塔街129282号楼
  318. 沈阳中海药业有限公司:辽宁省新民市东又营工业园区东营北二路6
  319. 沈阳中普生物制品有限公司:沈阳市皇姑区华山路442-8
  320. 施强药业股份有限公司:杭州市滨江区滨江区滨安路1168
  321. 石家庄以岭药业股份有限公司:石家庄开发区山大街238
  322. 石药集团恩必普药业有限公司:石家庄经济技术开发区扬子江路88
  323. 石药集团欧意药业有限公司:河北省石家庄市中山西路276
  324. 四川精正生物科技有限公司:吉林市昌邑区重庆路488
  325. 四川科伦药业股份有限公司:四川省成都市百花西路36
  326. 泰州新生源生物医药有限公司:泰州市药成大道
  327. 天津和美生物技术有限公司:天津市南开区科研西路12
  328. 天津红日药业股份有限公司:天津市武清开发区泉发路20
  329. 天津鸿群医疗器械科技有限公司:天津市河西区郁红道17号陈塘科技创业基地308
  330. 天津华津制药有限公司:天津市河北区水产前街28
  331. 天津金耀集团有限公司:天津市河东区八纬路1090801
  332. 天津力生制药股份有限公司:天津市南开区黄河道491
  333. 天津青松华药医药有限公司:天津市和平区西堤路72-74
  334. 天津生物工程职业技术学院:天津经济技术开发区西区南大街175
  335. 天津生物化学制药有限公司:天津空港经济区环河南路269
  336. 天津市捷安凯医药有限公司:天津市河西区大沽南路857号国华大厦1111
  337. 天津市新药安全评价研究中心:天津市滨海高新区滨海科技园惠仁街道308
  338. 天津市医药集团有限公司:天津市河西区友谊北路29
  339. 天津太平洋制药有限公司:天津市解放南路外环线17号桥
  340. 天津同仁堂集团股份有限公司:天津市河西区友谊北路29
  341. 天津药物研究院:天津市南开区鞍山西道308
  342. 天津药物研究院药业有限责任公司:天津市南开区玉泉路96
  343. 天津医药集团津康制药有限公司:天津市滨海新区大港石化产业园区金源路236
  344. 天津中新药业集团股份有限公司:天津市南开区白堤路17号中新大厦
  345. 天津中新药业集团股份有限公司乐仁堂制药厂:天津市西青区大明道2
  346. 天津中新药业集团股份有限公司新新制药厂:天津市东丽区程林庄工业区
  347. 天津中新药业销售公司:天津市南开区白堤路17
  348. 天津中新药业医药公司:天津市南开区白堤路17号中新大厦10
  349. 天津中央药业有限公司:天津市北辰区富锦道1
  350. 万全药业集团:北京市海淀区四季青金庄3号万全大厦
  351. 武汉恒信源药业有限公司:武汉市东湖高新技术开发区豹澥街神墩五路88
  352. 西安恒生堂制药有限公司:陕西省西安市新城区纬什街新科路1
  353. 西安力邦制药有限公司:西安高新区科技一路创业大厦C-708
  354. 西安利君制药有限责任公司:西安市汉城南路151
  355. 新疆神州通医药有限公司:新疆维吾尔自治区乌鲁木齐经济技术开发区农十二师合作区大别山街333
  356. 新疆银朵兰维药股份有限公司:乌鲁木齐市高新北区东融街675
  357. 徐州生物工程职业技术学院:江苏省徐州市三环西路
  358. 亚宝药业集团股份有限公司:山西省芮城县风陵渡经济开发区工业大道1
  359. 烟台东诚生化股份有限公司:山东省烟台市经济技术开发区长白山路7
  360. 扬子江药业集团有限公司:江苏省泰州市高港区扬子江南路1
  361. 宜昌人福药业有限责任公司:湖北省宜昌开发区大连路19
  362. 悦康药业集团有限公司:北京市经济技术开发区宏达中路6
  363. 浙江贝达药业有限公司:杭州市余杭经济开发区红丰路589
  364. 浙江昌海生物有限公司:浙江省绍兴市滨海新城世纪大道95
  365. 浙江车头制药股份有限公司:浙江省仙居县
  366. 浙江海森药业有限公司:浙江东阳市六石街道香潭社区
  367. 浙江海翔药业股份有限公司:浙江省台州市椒江区外沙支路100
  368. 浙江海正药业股份有限公司:浙江省台州市椒江区外沙路46
  369. 浙江惠松制药有限公司:浙江省杭州市下城区建国北路236号诚信大厦15
  370. 浙江金华康恩贝生物制药有限公司:金华市金衢路288
  371. 浙江京新药业股份有限公司:浙江省绍兴市新昌县羽林街道新昌大道东路800
  372. 浙江普洛康裕制药有限公司:浙江省东阳市横店镇江南路39
  373. 浙江省诚意药业有限公司:浙江省洞头县东屏镇化工路118
  374. 浙江仙琚制药股份有限公司:浙江省台州市仙居县仙药路1
  375. 浙江新华制药有限公司:浙江省化学原料药基地临海园区
  376. 浙江亚太药业股份有限公司:浙江省绍兴县云集路1152
  377. 浙江医药股份有限公司新昌制药厂:浙江省新昌县环城东路59
  378. 浙江震元制药有限公司:浙江省绍兴市袍江工业区越东路
  379. 珍奥集团股份有限公司:辽宁省大连市经济技术开发区双口港生命一路88
  380. 中国大冢制药有限公司:天津市西青区精武镇津文公路西中国大冢制药有限公司
  381. 中国国际医药卫生公司:北京市朝阳区惠新东街4
  382. 中国医疗器械有限公司:北京市朝阳区安定路39号长新大厦4
  383. 中国医药(集团)沈阳中沈医疗器械有限公司:沈阳市和平区太原北街20
  384. 中国医药集团总公司:北京市海淀区知春路20号中国医药大厦
  385. 中荷人寿保险有限公司辽宁分公司:沈阳市沈河区文艺路19号地王国际大厦8F
  386. 中卫康医药投资有限公司:北京市海淀区上地四街1号院2号楼301
  387. 中新药业药材公司:天津市南开区白堤路17号中新大厦9
  388. 重庆华邦制药有限公司:重庆市渝北区人和星光大道69
  389. 重庆赛诺生物药业股份有限公司:重庆市九龙坡区科园四街57
  390. 重庆药友制药有限责任公司:重庆市渝北区人和镇星光大道100
  391. 诸城市浩天药业有限公司:山东省诸城市辛兴镇
  392. 沈阳贝恩制药有限公司:沈阳市浑南新区文溯街16-7426
  393. 辽宁诺康生物制药有限公司:沈阳浑南新区
  394. 吉林吉春制药股份有限公司:四平市吉春路1
  395. 格仕特集团有限公司:辽宁省本溪市石桥子经济技术开发区
  396. 北京品源知识产权代理有限公司:北京市海淀区莲花池东路39号西金大厦6
  397. 辽宁中医学院药业有限公司:沈阳市沈北新区辉山大街148
  398. 国药一心制药有限公司:长春市高新区前进广场阳光大厦1305
  399. 北京斯丹姆赛尔技术有限责任公司:北京市西城区月坛南街261号楼4010
  400. 山东力诺药业集团:山东省济南市经十东路30766
  401. 北京宏润达科技发展有限公司:北京市海淀区太平路甲38
  402. 辽阳嘉德血液制品有限公司:辽宁省辽阳市白塔区卫国路146
  403. 北京同仁堂健康药业股份有限公司:北京市大兴区亦庄经济开发区景园北街258号楼
  404. 沈阳双鼎制药有限公司:沈阳市浑南新区高科路15
  405. 沈阳管城制药有限公司:辽宁省沈阳市
  406. 沈阳华卫医药有限公司