PIC/S技术标准指南体系分析  

The Analysis on PIC/S Technical Standards and Guidelines System

作　　者：颜若曦 YAN Ruo-xi(Center for Food and Drug Inspection of NMPA,Beijing 100076,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100076

出　　处：《中国药物评价》2024年第2期172-176,共5页Chinese Journal of Drug Evaluation

摘　　要：国家药品监督管理局已于2023年9月正式提交了加入药品检查合作计划(PIC/S)申请并已成为正式申请者。当前,PIC/S针对申请加入机构和制药行业颁发了大量的技术标准与指南,熟悉并掌握这些技术标准指南,有助于药品监管机构和制药行业更有效地推进和应对加入PIC/S工作。参考PIC/S网站,本文按照GMP标准、机构指南、指导文件、备忘录和其他文件的分类原则,对PIC/S发布的现行技术标准与指南进行了系统分析与梳理,从体系层面对其进行了研究,以期为业内机构和人员更好地理解PIC/S标准指南体系提供参考。The National Medical Products Administration(NMPA)submitted application to the Pharmaceutical Inspection Cooperation Program(PIC/S)officially in September 2023 and has become an official applicant.Nowadays,PIC/S published a large number of technical standards and guidelines for pharmaceutical regulatory agencies and industry.It would be helpful to drug regulatory agencies and the pharmaceutical industry become more effective to promote and respond to the application by familiarity and mastery these technical standards and guidelines.The study analyzes these technical standards and guidelines published by PIC/S according to the classification of GMP guides,inspectorates guidelines,guidance documents,aide-memoires and other documents.Based on the research on system level,it provides a reference for relevant units and individuals have a better understanding of PIC/S standard and guidance system.

关 键 词：药品检查 药品检查合作计划 药品生产质量管理规范 

分 类 号：R95[医药卫生—药学]