PIC/S GMP检查互信介绍及启示
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摘要
目的通过对国际药品检查合作组织(Pharmaceutical Inspection Co-operation Scheme,PIC/S)及其国家药品生产质量管理规范(good manufacturing practice,GMP)检查互信的介绍,为我国积极参与国际互认带来启示。方法结合PIC/S发布的GMP检查互信指南,从范围、评估流程及审查回顾3个方面对检查互信、境外工厂的现场检查豁免予以介绍。结果GMP检查互信的实施,不仅有助于整合仅有的检查资源,使其高效利用,还可以降低监管机构或组织及药品生产企业的成本。结论申请加入PIC/S并参与国际互信将在共享信息、建立职业化检查队伍、提升GMP行业标准和国际影响力方面给我国带来诸多优势。
OBJECTIVE To provide inspiration for our regulatory authority and drug manufacturers in international GMP inspection and mutual recognition through the introduction of PIC/S and GMP inspection reliance. METHODS Combined with the guidance of GMP inspection reliance, the introduction and assessment of an onsite inspection GMP of a manufacturing facility in an overseas territory in not required from the scope, process, monitoring and review. RESULTS Due to the implementation of GMP inspection reliance, it was not only help to integrate global inspection resources, but also reduced duplication of work and cost of regulatory authorities or manufacturers. CONCLUSION There are many benefits for them to apply for PIC/S membership and participate in mutual recognition in certain aspects, such as sharing information, establishing a professional inspection team, improving GMP standards and international influence.
OBJECTIVE To provide inspiration for our regulatory authority and drug manufacturers in international GMP inspection and mutual recognition through the introduction of PIC/S and GMP inspection reliance. METHODS Combined with the guidance of GMP inspection reliance, the introduction and assessment of an onsite inspection GMP of a manufacturing facility in an overseas territory in not required from the scope, process, monitoring and review. RESULTS Due to the implementation of GMP inspection reliance, it was not only help to integrate global inspection resources, but also reduced duplication of work and cost of regulatory authorities or manufacturers. CONCLUSION There are many benefits for them to apply for PIC/S membership and participate in mutual recognition in certain aspects, such as sharing information, establishing a professional inspection team, improving GMP standards and international influence.
引文
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[13]黄文慧,田少雷,董江萍,等.PIC/S检查员培训体系及对完善我国药品检查员培训制度的启迪[J].中国药事,2017,31(11):1277.
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[17]KATORI N.Accession to the PIC/S and pharmaceutical quality system in Japan[J].Bull Natl Inst Health Sci,2014(132):22-35.
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[19]HE T T,UNG C O L,HU H,et al.Good manufacturing practice(GMP)regulation of herbal medicine in comparative research:China GMP,cGMP,WHO-GMP,PIC/S and EU-GMP[J].Eur J Integrat Med,2015,7(1):55-66.
[20]孙煜,张喻,魏晓翠,等.湖北省职业化药品检查员队伍建设探索[J].中国药师,2018,21(10):1835-1837.
[21]Pharmaceutical Inspection Co-operation Scheme.PIC/S GMPGUIDE(INTRODUCTION)[EB/OL].[2019-2-22].https://picscheme.org/layout/document.php?id=1410.
[22]李琦.加入PIC/S与推动我国参与GMP国际互认[J].中国药房,2007,18(16):1203-1205.
[2]国家药品监督管理局.数据查询[EB/OL].[2018-12-14].http://qy1.sfda.gov.cn/datasearchcnda/face3/base.jsp?tableId=34&tableName=TABLE34&title=%E8%8D%AF%E5%93%81%E7%94%9F%E4%BA%A7%E4%BC%81%E4%B8%9A&bcId=152911762991938722993241728138.
[3]国家药品监督管理局.国家药品监督管理局办公室关于公布新聘任国家药品GMP检查员名单的通知[EB/OL].[2018-12-14].http://www.nmpa.gov.cn/WS04/CL2196/229607.html.
[4]国家药品监督管理局.总局办公厅关于公布第一批重新聘任的国家药品GMP检查员名单的通知[EB/OL].[2018-12-14].http://www.nmpa.gov.cn/WS04/CL2196/324147.html.
[5]国家药品监督管理局.总局办公厅关于公布第一批重新聘任的国家药品GMP检查员名单的通知[EB/OL].[2018-12-14].http://www.nmpa.gov.cn/WS04/CL2196/324149.html.
[6]国家药品监督管理局食品药品审核查验中心.关于启动2018年药品境外生产现场检查有关事宜的通知[EB/OL].[2018-12-14].https://www.cfdi.org.cn/resource/news/9734.html.
[7]国家药品监督管理局.国家药品监督管理局关于发布《2017年度药品检查报告》的公告[EB/OL].[2018-12-14].http://www.nmpa.gov.cn/WS04/CL2182/228316.html.
[8]国家药品监督管理局.2016年度药品检查报告[EB/OL].[2018-12-14].http://www.nmpa.gov.cn/WS04/CL2196/324179.html.
[9]Pharmaceutical Inspection Co-operation Scheme.GMPInspection Reliance[EB/OL].[2018-12-14].https://picscheme.org/layout/document.php?id=1400.
[10]Pharmaceutical Inspection Co-operation Scheme.Introduction[EB/OL].[2018-12-14].https://picscheme.org/en/about.
[11]Pharmaceutical Inspection Co-operation Scheme.Mission,Vision and Values[EB/OL].[2018-12-14].https://picscheme.org/en/mission-vision-and-values.
[12]Pharmaceutical Inspection Co-operation Scheme.History of PIC/S[EB/OL].[2018-12-14].https://picscheme.org/en/history.
[13]黄文慧,田少雷,董江萍,等.PIC/S检查员培训体系及对完善我国药品检查员培训制度的启迪[J].中国药事,2017,31(11):1277.
[14]张卓光.PIC/S、PIC/S GMP与中国GMP的比较研究[J].中国药事,2010,24(3):302.
[15]Pharmaceutical Inspection Co-operation Scheme.Members[EB/OL].[2018-12-15].https://picscheme.org/en/members.
[16]GOUWS J.FDA obtains sought-after PIC/S membership[J].Pharmaceut Technol,2011,35(2):83.
[17]KATORI N.Accession to the PIC/S and pharmaceutical quality system in Japan[J].Bull Natl Inst Health Sci,2014(132):22-35.
[18]Pharmaceutical Inspection Co-operation Scheme.Benefits[EB/OL].[2018-12-14].https://picscheme.org/en/benefits.
[19]HE T T,UNG C O L,HU H,et al.Good manufacturing practice(GMP)regulation of herbal medicine in comparative research:China GMP,cGMP,WHO-GMP,PIC/S and EU-GMP[J].Eur J Integrat Med,2015,7(1):55-66.
[20]孙煜,张喻,魏晓翠,等.湖北省职业化药品检查员队伍建设探索[J].中国药师,2018,21(10):1835-1837.
[21]Pharmaceutical Inspection Co-operation Scheme.PIC/S GMPGUIDE(INTRODUCTION)[EB/OL].[2019-2-22].https://picscheme.org/layout/document.php?id=1410.
[22]李琦.加入PIC/S与推动我国参与GMP国际互认[J].中国药房,2007,18(16):1203-1205.