实验室CNAS与GMP管理体系融合探索  

Exploration of CNAS-GMP System Integration of Testing Laboratory

作　　者：徐婷 陶金 俞静 蒋道英 岳镭 XU Ting;TAO Jin;YU Jing;JIANG Dao-ying;YUE Lei(Shanghai Hutchison Pharmaceuticals)

机构地区：[1]上海和黄药业有限公司

出　　处：《中国标准化》2022年第7期237-241,共5页China Standardization

摘　　要：CNAS认证是国家认证认可监督管理委员会对实验室技术能力的认可,对于提高检测实验室管理水平有积极的推动意义,CNAS管理体系与GMP质量管理体系既有相似的地方也有不同之处,如何将两套管理体系有机融合成为了实验室新的挑战。本文在规范高效管理的基础上,系统剖析CNAS与GMP体系对实验室各要素的要求,分析异同,提出有效融合的方法,为检测实验室管理提供新思路。CNAS certification is the accreditation of laboratory by Certification and Accreditation Administration of the P.R.C.,which has a positive significance in improving laboratory’s administrative level.CNAS management system has similarities and differences with GMP.How to organically integrate the two sets of management systems becomes a new challenge for testing laboratory.On the basis of normalized and efficient management,the paper systematically analyzes the requirements of CNAS and GMP management systems based on laboratory essential factors,analyzes the similarities and differences,puts forward effective integration methods and innovative hinking for testing laboratory.

关 键 词：CNAS GMP 体系融合 实验室 

分 类 号：TQ460.8[化学工程—制药化工] F203[经济管理—国民经济]