摘要
本文以《检验检测机构资质认定评审准则》和《检测和校准实验室能力认可准则》及其在微生物和化学检测领域的应用说明(CNAS-CL01、CNAS-CL09、CNAS-CL10)为基础,通过解读条款内容及要求,提炼出药品检验实验室的内审要点,建立了符合药品检验实验室实际运行情况的内审核查方法和体系,为同类实验室内审提供范本。
Through studying the items and requirements in Testing institutions aptitude assessment criteria, Testing and calibration laboratory capability approval criteria and the application specification in microbial and chemical inspection field（CNAS-CL01, CNAS-CL09, CNAS-CL10）, the key points of internal audit in drug control laboratories have been refined and the audit method and system has been established, which complies with practical situation in drug control laboratories. Thus a template for internal audit will be provided to similar laboratories.
出处
《中国医药导报》
CAS
2016年第15期181-184,188,共5页
China Medical Herald
关键词
药检实验室
内审
要点
Drug control laboratories
Internal audit
Key points
