2018年FDA审计重点

shenjianwei · 发表于 2019-1-7 12:41:19

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2018年FDA审计，一大半发现项在QC和OOS/偏差调查方面。
  Citation  Program Area  Cite Id  Reference  Number  Short  Description  Long  Description  Frequency
  Drugs  1105  21 CFR  211.22(d)  Procedures  not  in writing, fully followed  The  responsibilities and procedures applicable to the quality control unit are  not [in writing] [fully followed]. Specifically, ***  208
  Drugs  3603  21  CFR 211.160(b)  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, ***  127
  Drugs  2027  21  CFR 211.192  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, ***  107

北重楼 · 发表于 2019-1-7 13:02:51

有中文版的吗

syhorchid · 发表于 2019-1-7 13:08:33

了解一下

lhd000000 · 发表于 2019-1-7 13:16:01

英文不好

kc1711422001 · 发表于 2019-1-7 16:25:09

Thanks for sharing

麦田.守望 · 发表于 2019-1-7 21:25:47

excel转pdf
https://www.fda.gov/downloads/ICECI/Inspections/UCM628362.xlsx

夜b7a2c7e6 · 发表于 2019-1-14 10:52:44

学习啦，大大

pkdongxun · 发表于 2019-1-14 11:21:56

认真学习~ 谢谢~

其实我是傲娇 · 发表于 2019-1-14 16:13:04

康康怎么样

jiangkuiab · 发表于 2019-2-2 12:35:07

谢谢回复

zsai · 发表于 2019-2-12 16:32:28

谢谢！谢谢！谢谢！

怪咖一样吊 · 发表于 2019-5-15 15:54:55

有中文版的嘛

olivia姚 · 发表于 2019-5-24 14:53:00

警告信基本都差不多，最近对微生物和水系统的关注度提升了。

火狐贝宁 · 发表于 2023-5-25 07:58:13

Thanks for sharing

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