对药品GMP质量管理体系中变更控制、偏差管理、质量风险管理的探讨

On Alternation Control Deviation Management and Quality Risk Management in Drug GMP Quality Management System

目的:概述质量管理体系中变更控制、偏差管理、质量风险管理的内容,对药品生产企业完善质量管理体系进行探讨。方法:以某药品生产企业质量管理体系为依据,以《药品生产质量管理规范》与近年来国内发表的文献为指导,进行归纳、总结与分析。结果与结论:药品生产企业应该加强质量管理体系建设,将偏差处理、变更、风险评估放在重要地位,学习先进的理论和方法,提高质量管理水平,最终完善质量管理体系。

Objective：To summarize the contents of alternation control,deviation management and quality risk management in the quality management system,so as to improve the quality management system in the pharmaceutical production enterprises.Methods：We summarized and analyzed the quality control standards by using the quality management system in one production enterprise as a basis and the guidance of GMP and the literatures published recently in China.Results and Conclusion：The pharmaceutical production enterprises should strengthen the construction of the quality management system,give priority to deviation management,alternation and risk assessment,and learn advanced theory and method,so as to improve the quality management level,and ultimately improve the quality management system.