WHO关于危害分析和关键控制点方法在药品中的应用介绍

Introduction on the WHO Guidance:Application of Hazard Analysis and Critical Control Point(HACCP) Methodology to Pharmaceuticals

危害分析和关键控制点(HACCP)作为食品行业的质量安全管理体系,旨在预防已知的危害和减少这些危害可能发生在食品生产链中某些特定环节中的危险,是一种包含风险评估和风险管理的控制程序,被认为是迄今为止控制食源性危害最经济、最有效的手段。目前HACCP已被越来越多地应用于食品行业以外的其他行业。WHO制订的"危害分析和关键控制点(HACCP)方法在药品中的应用",目的是协助制药工业建立和实施有效的HACCP计划。本文对该指南的主要内容进行了介绍,包括主要专业术语及其定义,HACCP与GMP及验证的关系,HACCP应用的意义及应用指导原则,培训教育及实施步骤等。

Hazard Analysis and Critical Control Point （HACCP） is increasingly being applied in other industries besides the food industry. The new guidance ＂Application of Hazard Analysis and Critical Control Point（HACCP） Methodology to Pharmaceuticals＂ developed by WHO are aimed at assisting pharmaceutical industry to develop and implement effective HACCP plans. The main contents, including the definitions, differences between HACCP and GMP as well as validation, the principles and the guidelines for the application of HACCP system, training and education, and the stages of HACCP application, etc. are described in this paper.