WHO药品预认证微生物实验室质量管理的要求与思考

目的:介绍世界卫生组织(WHO)对药品微生物检测实验室的预认证要求,推动我国药品检测质量管理体系的完善和发展。方法:从预认证实验室应遵循的质量管理原则出发,对照我国实验室ISO/IEC 17025体系要求,分析药品微生物检测实验室在质量管理中的不足。结果:预认证实验室更多地采纳了《药品生产质量管理规范》(GMP)的质量管理理念,而我国药品微生物检测实验室在记录与数据可靠性、基于风险的变更控制和偏差调查等方面的应用与实施还存在较大差距。结论:我国药品微生物检测实验室应学习和借鉴国内外GMP的质量管理经验,不断更新理念,改进质量管理体系,更多地以风险评估方式保障检测数据的可靠性。

Requirements and Reflection on Quality Management of WHO Prequalified Pharmaceutical Microbiology Laboratories

Objective: To improve and develop quality management of pharmaceutical testing in China by introducing the prequalification requirements for pharmaceutical microbiology laboratories of World Health organization (WHO). Methods: Based on the principles of quality management to be followed by prequalified laboratories, by comparison with the requirements of ISO/IEC 17025 system of China, the shortcomings of quality management of the pharmaceutical microbiology laboratories were analyzed. Results: Most of the prequalified laboratories adopts the quality management concept of good manufacturing practice (GMP). There is huge difference between the domestic microbiology laboratories and prequalified laboratories in the area of record and data integrity, risk-based change control and deviation investigation, etc. Conclusion: The pharmaceutical microbiology laboratories of China should learn from the quality management experience of GMP at home and abroad, update concepts continuously, improve the quality management system, and ensure the reliability of test data by risk assessment.