非无菌药品中不可接受微生物的检验控制策略

Testing Control Strategy of Objectionable Microorganisms in Non-sterile Products

目的:为药品生产企业识别从非无菌产品和原辅料分离的微生物是否是不可接受微生物以及建立对应的控制策略提供参考。方法:通过分析《中华人民共和国药典》、美国药典和欧洲药典现行版关于“不可接受微生物”描述,以及《中华人民共和国药品管理法》中关于药品质量以及安全用药等要求,总结不可接受微生物判定标准;基于人用药品注册技术国际协调会(ICH Q6A)、《中华人民共和国药典》、美国药典和欧洲药典关于微生物限度检查要求的比较,给出具体剂型以及原辅料不可接受微生物控制策略。结果与结论:非无菌产品中存在的不可接受微生物有可能降低或妨碍产品疗效,影响产品质量,对消费者健康有潜在风险,而目前药典中无清晰的定义和检验控制策略,生产企业应建立系统、清晰和可操作性的不可接受微生物风险识别和控制策略,指导操作者进行不可接受微生物评估。

Objective:To provide the reference for pharmaceutical manufacturers to determine if microorganisms recovered from non-sterile products,excipients and active pharmaceutical Ingredients are objectionable,and to establish corresponding control strategy.Methods:Summary the judgment criteria for objectionable microorganisms based on the requirements in Ch.P,USP,EP and Drug Administration Law of the People's Republic of China;Establish the testing control strategy based on ICH Q6A,Ch.P,USP and EP.Results and Conclusion:The presence of objectionable microorganisms in non-sterile products may reduce or inactivate the efficacy of the product,aff ect the product quality,and has a potential risks to the health of consumers,however there is no clear definition and testing control strategy in current pharmacopeia.The manufacturer should establish a systematic,clear and operable risk identification and control strategy for objectionable microorganism and guide operators to evaluate objectionable microorganisms.