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欧美GMP法规检查的现场应对:针对制药企业如何做好欧美药管当局法规检查的准备工作的探讨

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摘要 本文讨论制药企业如何做好欧美药管当局法规检查的准备工作包括如何降低或消除法规检查中的常见风险。法规当局对制药企业的检查,通常分为药品上市前的批准前检查,和药品上市后的GMP符合性检查。
作者 刘禹
出处 《现代包装》 2014年第3期58-58,60,61,共3页 Packaging
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参考文献8

  • 1FDA, Compliance Program Guidance Manual Program 7356.002, Drug Manufacturing Inspections, 2002.
  • 2FDA, Compliance Program Guidance Manual Program 7356.002F, Active Pharmaceutical Ingredient (API) Process Inspection, 2006.
  • 3刘禹.GMP环境下的记录管理方法[J].医药工程设计,2012,33(3):22-27. 被引量:6
  • 4FDA, Compliance Program Guidance Manual Program 7346.832, Pre-Approval Inspection, 2012.
  • 5FDA, Guidance for Industry: Refusal of Inspection or Access to ttACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products, 2001.
  • 6FDA, Investigation Operation Meamal, 2013.
  • 7EMA, EMA/385898/2013 Rev 16, Compilation of Community Procedures on Inspections and Exchange of lnlbnnation, 2013.
  • 8EMA/TGA/FDA/EDQM, EMA/ INS/GMP/129953/2012, Programme to Rationaliselnternational GMP Inspections of active pharmaceutical ingredients/active substances manufacturers, 2012.

二级参考文献8

  • 1FDA, Compliance Program Guidance Manual 7356.002f, "Pre- Approval Inspections" , 2010.
  • 2FDA, Compliance Program Guidance Manual 7356.002f, "Active Pharmaceutical Ingredient (API) Process Inspection" , 2006.
  • 3FDA, Compliance Program Guidance Manual 7356.002, "Drug Manufacturing Inspection" , 2002.
  • 4FDA, Guidance for Industry: Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products, 2001.
  • 5美国国会,FederalFood,Drug,andCosmeticAct,Section301(f).
  • 6美国国会众议院司法委员会,Federal Rules of Evidence.Rules607,608,609.
  • 7PhRMA CMC Statistics and Stability Expert Teams, Identification of Out-of-Trend Stability Results, 2003.
  • 8PhRMA CMC Statistics and Stability Expert Teams, Identification of Out-of-Trend Stability Results (Part I1), 2005.

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