| 引用本文: | 李年苏,梁毅.PIC/S GMP检查互信介绍及启示[J].中国现代应用药学,2019,36(14):1833-1836. |
| LI Niansu,LIANG Yi.Introduction and Enlightenment of GMP Inspection Reliance in PIC/S[J].Chin J Mod Appl Pharm(中国现代应用药学),2019,36(14):1833-1836. |
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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。 |
| 关键词: 国际药品检查合作组织 药品生产质量管理规范 检查互信 启示 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.14.023 |
| 分类号:R951 |
| 基金项目: |
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| Introduction and Enlightenment of GMP Inspection Reliance in PIC/S |
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LI Niansu, LIANG Yi
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China Pharmaceutical University, Nanjing 211198, China
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| Abstract: |
| 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. |
| Key words: PIC/S GMP inspection reliance enlightenment |
