ICH Q9和ICH Q10背景下的偏差管理 中英文 X.pdf

Deviation management in the context of ICH Q9/Q10 ICHQ9/Q10 背景下的偏差管理 European Journal of Parenteral Pharmaceutical Sciences 2008; 13(3): 31-35 © 2008 Pharmaceutical and Healthcare SciencesSociety Deviation management in the context of ICH Q9/Q10 ICHQ9/Q10 背景下的偏差管理 Canadell Heredia, E Garcia Vidal, S Herrero Sas, J Llaja Villena, L Noguera Salvans, A Piñas Llagostera, D Puñal Peces, E Tardío Pérez, A Tébar Pérez ICH Q9 Quality Risk Management working party of the Quality Assurance Committee of the Catalan Section of the Spanish Association of Industrial Pharmacists (AEFI) The Spanish Association of Industrial Pharmacists (AEFI) monograph ICH Q9 Quality Risk Management not only describes the general principles of risk management set out in that guideline, but also takes an approach that is highly practical for the pharmaceutical industry. It therefore contains examples of how to use various risk analysis tools, including definitions, usage, objectives, operation, and advantages and disadvantages in each case. This article forms part of one of the examples of the use of failure mode and effects analysis (FMEA) risk analysis tools. Key words: ICH Q9/Q10, risk management, critical and non-critical deviations, flowchart, failure mode and effects analysis Introduction: deviation management issues 介绍：偏差管理问题 In general terms, a deviation is non-compliance with an established standard. The EU Guide to Good Manufacturing Practice (GMP) states that any deviation from the approved requirements and procedures must be documented and explained. 一般而言，偏差就是不符合已建立的标准。欧盟 GMP 指导原则写明任何偏离已批准需求 和程序的偏差都必须记录并解释。 The concept of deviation is so broad that deviation management as applied to the pharmaceutical industry presents a few problems, such as: 偏差的概念是如此