申请加入PIC/S对药品检查体系建设的启示OA
Implications of Applying for PIC/S Membership for the Development of Drug Inspection System
药品检查合作计划(PIC/S)是国际药品监管领域的重要组织.PIC/S审计清单是申请者加入该组织的重要评价标准,共包含78项具体指标.本文结合PIC/S审计清单的指标要求,分析我国药品检查机构药品检查体系的运行情况和面临的挑战,并针对分析发现的问题,探索提出合理对策与具体改进措施,以期为药品检查机构构建与国际接轨的药品检查体系提供参考,促进药品检查机构药品检查体系与PIC/S标准协调一致.
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.
杜婧;王鑫;周勇
国家药品监督管理局食品药品审核查验中心山东省食品药品审评查验中心山东省食品药品审评查验中心
医药卫生
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
Pharmaceutical Inspection Co-operation Scheme(PIC/S)audit checklistdrug inspection systeminspector managementinspection informatizationstandardization of inspection procedures
《中国食品药品监管》 2026 (5)
120-127,8
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