PIC/S GMP先进治疗产品附录与我国细胞治疗产品生产质量管理指南的对比分析

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。

Comparative Analysis of the GMP Appendix of PIC/S Advanced Therapeutic Medicinal Products and Manufacture Quality Management Guidelines of China's Cell Therapy Products

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.