药品GMP实施及认证中偏差分析、风险评估、质量回顾分析的探讨

目的提升药品生产企业在新版GMP实施中对偏差分析处理、风险评估、质量回顾分析的理解和执行水平。方法对企业实施偏差分析处理、风险评估、质量回顾分析的情况进行梳理,并进行原因分析,探讨改进对策。结果偏差分析、风险评估、回顾性质量分析规程规定不够完善,偏差定义不够明晰,逻辑关联性分析欠缺。结论药品生产企业应完善方法与规程,强化外部供应服务、设计、变更、规程、方案、计划、记录、报告、投诉、ADR报告等确认审核,推进电子数据库建设,建立对偏离事项的扫描识别和警示程序,确保发现及时,溯源、追溯到位,评估准确、管控有效。

Discussion about Variance Analysis,Risk Assessment,Retrospective Analysis of Quality in the Implementation and Certification of Drug GMP

Objective To promote understanding and the performance in variance analysis, risk evaluation, retrospective analysis of quality of pharmaceutical manufacturing enterprises in the GMP implementation. Methods The varianceanalysis, risk evaluation, retrospective analysis of quality were conducted and the countermeasures were investigated. Results The procedures of variance analysis, risk evaluation, retrospective analysis of quality were not optimal, the deviation definition was not clear enough and the logical correlation analysis was defective. Conclusion In order to ensure quick detection, timely and precise tracing of problems, accurate evaluation and efficient control of the manufacture procedures, the pharmaceutical enterprises should improve manufacture methods and optimize procedures; enhance the confirmation and audit of eternal supply service, designing, alteration, procedures, programming, planning, recording, complaint and ADR reports; and promote the construction of electronic database as well as establish the scanning identification and warning program.