国际药品检查组织(PIC/S)审计清单文件的解析  

An analysis of audit checklist of Pharmaceutical Inspection Co-operation Scheme(PIC/S)

作　　者：石天放 曹轶 董江萍 杨悦 SHI Tian-fang;CAO Yi;DONG Jiang-ping;YANG Yue(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;Center for Food and Drug Inspection of National Medical Products Administration,Beijing 100044,China;School of Pharmaceutical Sciences,Tsinghua University,Beijing 100084,China)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]国家药品监督管理局食品药品审核查验中心,北京100044 [3]清华大学药学院,北京100084

出　　处：《中国新药杂志》2022年第2期177-182,共6页Chinese Journal of New Drugs

摘　　要：审计清单(audit checklist)是国际药品检查组织(Pharmaceutical Inspection Co-operation Scheme,PIC/S)评估申请加入机构的指标,PIC/S借此对申请机构药品监管检查体系进行全面的评估。本文通过对审计清单各模块和相关指标进行梳理解读,分析并提出相关建议,为推进我国加入PIC/S工作提供参考。结合PIC/S发布的审计清单及相关指南,从各模块指标重要程度、评估方式、主要评估内容等角度分别介绍并初步评估我国存在的差距,提出相关建议。PIC/S审计清单有11个模块,38项亚指标,包含78项具体指标,我国在加入PIC/S过程中应当重点关注法律法规体系、质量管理体系、检查机制、培训体系等方面的改进。针对与PIC/S加入要求的差距进行改进,从而加快我国加入PIC/S的进程,促进我国药品检查工作的国际化。Audit checklist is an index used by the International Pharmaceutical Inspection Co-operation Scheme(PIC/S)to evaluate applicants to join the organization.PIC/S uses this to conduct a comprehensive evaluation of the drug regulatory inspection system of the applicant organization.This article combs through the various modules and relevant indicators of the audit checklist,analyzes and puts forward relevant suggestions,and provides references for advancing China's accession to PIC/S.Combined with the audit checklist and relevant guidelines issued by PIC/S,this paper introduced and preliminarily evaluated the gaps existing in China from the perspectives of the importance of indicators of each component,evaluation methods and main evaluation contents,and put forward relevant suggestions.PIC/S audit checklist has 11 components,38 sub-components,including 78 specific indicators.China should focus on the improvement of laws and regulations system,quality management system,inspection mechanism,training system and so on in the process of joining PIC/S.Improvement needs to be made according to the gaps with PIC/S accession requirements,so as to speed up the process of China's accession to PIC/S and promote the internationalization of drug inspection in China.

关 键 词：国际药品检查组织(PIC/S) 药品生产质量管理规范 审计清单 加入程序 

分 类 号：R95[医药卫生—药学]