目的：为我国申请加入药品检查合作计划(PIC/S)，建立与国际统一的检查标准，提出细胞治疗产品GMP检查亟需关注的差异点。方法：对我国细胞治疗产品指南与PIC/S先进治疗产品GMP附录进行整体梳理和对比分析，并就一些关键问题进行了讨论。结果：我国与PIC/S GMP附录原则及考虑要素基本是一致的，但从法规体系、框架结构、适用范围、具体要求均有所区别。结论：分别从质量风险管理、起始生物材料的检查、与国际检查标准的统一三个方面提出了对此类产品GMP检查的启示。
Abstract
Objective: For China to apply for joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S), establish internationally unifi ed inspection standards, and put forward the diff erences that need urgent attention in GMP inspection of cell therapy products. Methods: The overall combing and comparative analysis of China's cell therapy product guidelines and the GMP appendix of PIC/S advanced therapeutic medicinal products were carried out, and some key issues were discussed. Results: The principles and considerations of China and PIC/S GMP appendix are basically the same, but they are diff erent from the regulatory system, framework structure, scope of application, and specifi c requirements. Conclusion: The enlightenment for GMP inspection of such products is proposed from three aspects: quality risk management, inspection of starting biological materials, and unifi cation with international inspection standards.
关键词
药品检查合作计划；先进治疗产品；药品生产质量管理规范；细胞治疗；药品检查
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Key words
Pharmaceutical Inspection Co-operation Scheme (PIC/S)； Advanced Therapy Medicinal Products (ATMP)； Good Manufacture Practice (GMP)； cell therapy； drug inspection
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