2020年版《中国药典》中药标准检测方法转版工作的体会  

Experience in Transitioning to Testing Standards for Traditional Chinese Medicine in Chinese Pharmacopoeia(2020 Edition)

作　　者：王莹[1] 项新华[1] 张聿梅[1] 金红宇[1] 马双成[1] 于健东[1] WANG Ying;XIANG Xin-hua;ZHANG Yu-mei;JIN Hong-yu;MA Shuang-cheng;YU Jian-dong(National Institutes for Food and Drug Control)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国食品药品监管》2021年第9期44-48,共5页China Food & Drug Administration Magazine

摘　　要：本文梳理了2020年版《中国药典》中涉及中药检验标准的更新内容以及中国合格评定国家认可委员会(CNAS)对标准变更的确认要求,依据规定并结合自身情况制定实验室内部的转版方案,对标准变更的注意事项进行了探讨,以期不断提升实验室的技术能力及质量管理水平,同时为中药检验检测机构开展实施药典的转版工作提供参考。This study summarizes the updates in the Chinese Pharmacopoeia(2020 Edition)related to traditional Chinese medicine testing standards and the confirmation requirements of CNAS for the standard changes.Based on these regulations and the actual situation of NIFDC,an internal plan for transitioning to the new standards at the laboratory is formulated,and matters needing attention are discussed.The aim is to improve the technical capability and quality management of the laboratory and provide insights for implementation of the revised TCM standards at other TCM testing institutions.

关 键 词：中国药典 中药检测 转版工作 标准 质量管理 

分 类 号：R921.2[医药卫生—药学]