中国食品药品监管Issue(5)：120-127,8.DOI:10.3969/j.issn.1673-5390.2026.05.010
申请加入PIC/S对药品检查体系建设的启示
Implications of Applying for PIC/S Membership for the Development of Drug Inspection System
杜婧 1王鑫 2周勇2
作者信息
- 1. 国家药品监督管理局食品药品审核查验中心
- 2. 山东省食品药品审评查验中心
- 折叠
摘要
Abstract
The Pharmaceutical Inspection Co-operation Scheme(PIC/S)is a significant international organization in the field of pharmaceutical regulation.The PIC/S Audit Checklist serves as a key evaluation criterion for applicants seeking membership and consists of 78 indicators.Based on the requirements of the PIC/S Audit Checklist,this paper analyzes the current operation of China's pharmaceutical inspection system and the challenges faced by drug inspection agencies.In response to the issues identified,this paper further explores and proposes targeted countermeasures and specific improvement measures,aiming to provide references for drug inspection agencies to establish inspection systems aligned with international standards and to promote harmonization with PIC/S requirements.关键词
药品检查合作计划/审计清单/药品检查体系/检查员管理/检查信息化/检查程序规范化Key words
Pharmaceutical Inspection Co-operation Scheme(PIC/S)/audit checklist/drug inspection system/inspector management/inspection informatization/standardization of inspection procedures分类
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杜婧,王鑫,周勇..申请加入PIC/S对药品检查体系建设的启示[J].中国食品药品监管,2026,(5):120-127,8.
