我国加入国际药品检查组织(PIC/S)存在的问题及建议  

Suggestions on Promoting China’s Drug Regulatory Agency to Join Pharmaceutical Inspection Co-operation Scheme(PIC/S)

作　　者：张军 董丽[1] Zhang Jun(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016 [2]黑龙江省市场监督管理人才培养发展中心,黑龙江哈尔滨150076

出　　处：《黑龙江医药》2023年第3期600-603,共4页Heilongjiang Medicine journal

摘　　要：目的:识别并减少我国药品GMP检查与PIC/S标准审计清单对标的差距,发现关键改进项目,有针对性地进行完善和修订,对于我国早日加入PIC/S组织具有很大的帮助。方法:本文首先介绍了PIC/S组织的概况、审计清单目录,以及分析几个典型国家加入的情况,并梳理了我国参与PIC/S活动的历程,然后参考PIC/S审计清单文件的内容,同时分析了我国在药品质量检查中存在的差异,从实践角度提出了对策建议。结论:我国GMP检查依然存在许多问题,文章有针对性地提出了完善和改变建议,为我国各级药品检查机构发展计划的制定提供参考。Objective:To identify and reduce the gap between China’s drug GMP inspection and PIC/s audit checklist,find out the key improvement items,improve and revise them pertinently,which will be helpful to promote the process of China joining PIC/s.Methods:This paper first introduces the general situation of PIC/S organization,audit checklist,and analyzes the accession of several typical countries which joined the organization,and sorts out the process of China’s participation in PIC/S activities,and then referring to the contents of PIC/S audit checklist,analyzed the problems of GMP inspection system in China,put forward suggestions for improvement.Conclusion:There are still many problems in GMP inspection in China.The article puts forward some suggestions for improvement and change,which can provide reference for the development of drug inspection agencies at all levels.

关 键 词：GMP检查 药品检查合作计划(PIC/S) 审计清单 药品监管机构 

分 类 号：R95[医药卫生—药学]