药品检验用仪器设备性能验证指导原则和技术标准的探讨

目的 为了规范我国药品检验用仪器设备性能验证工作,加快国内药品检验机构在仪器设备质量控制和管理方面与国际先进实验室接轨,符合世界卫生组织药品预认证的相关要求.方法 概述了仪器设备性能验证的基本概念和内容,验证工作的必要性,国内外性能验证的基本情况以及差距,探讨了国内药品检验机构开展性能验证的思路和方法,借鉴了北京市药品检验所开展高效液相色谱仪性能验证的经验.结果 引进国际先进的4Q模型理论可以帮助国内药品检验机构有效提升仪器设备质量控制和管理水平,开展仪器设备性能验证工作,符合国内外监管机构和权威组织的法规和认证要求.结论 尽快制定国内药品检验领域仪器设备性能验证指导原则和技术标准是促进我国药品检验机构和制药企业参加国际合作和竞争的重要技术保障.

Investigate the Performance Validation Guidelines and Technical Standards of Drug Testing Equipment

Objective To standardize qualification of drug testing instruments and equipment, to help the domestic inspection agencies to adopt international standards in quality control and management and meet the prequalification requirements of World Health Organization. Methods The paper summarizes the basic concepts and contents of the instruments and equipment performance qualification, explains the necessity of qualification and different practices at home and abroad, and expounds the method adopted by domestic drug inspection agencies by taking for example the HPLC qualification from Beijing Institute for Drug Control. Results The 4Q model can help domestic drug inspection agencies with their quality control and management level, and promote the qualification of instruments to meet the requirements of international organizations. Conclusion It is suggested that guidelines and technical standards for domestic qualification of instruments and equipment be established, which will provide technical support for Chinese drug inspection agencies and pharmaceutical enterprises to participate in international cooperation and competition.