PIC/S GMP无菌药品附录对我国无菌药品检查的影响

The Implications of PIC/S GMP Sterile Medicinal Products Appendix to the Inspection of Sterile Medicinal Products in China

目的:通过分析PIC/S GMP附录《无菌药品的生产》,为我国无菌药品检查与国际化接轨提供借鉴。方法:通过对PIC/S GMP无菌药品附录的主要内容以及与我国现行版GMP无菌药品附录进行对比分析,结合我国无菌药品生产检查中的常见问题,为完善我国无菌药品GMP检查提供建议。结果与结论:修订后的PIC/S GMP无菌药品附录对比我国现有的GMP无菌药品附录从概念和内容都有了相当大的更新,体现了药品监管的与时俱进,提示我们在规范检查、提升检查水平的同时,应引导企业主动了解国际先进的质量管理理念,向国际水平和国际标准靠拢,提升我国无菌药品生产行业的整体水平。

Objective:To provide reference for the internationalization of sterile medicinal products inspection in China by analyzing the GMP appendix of PIC/S"Manufacture of Sterile Medicinal Products".Methods:Through the analysis of the main contents of the PIC/S GMP sterile medicinal products appendix and the diff erences with the current GMP sterile medicinal products appendix in China,combined with the common problems in the manufacture inspection of sterile medicinal products in China,suggestions for improving the GMP inspection of sterile medicinal products in China were provided.Results and Conclusion:Compared with the existing GMP sterile medicinal products appendix in China,the revised PIC/S GMP sterile medicinal products appendix has been considerably updated in concept and content,refl ecting the progress of drug regulation with the times,suggesting that while standardizing inspection and improving the level of inspection,we should guide enterprises to take the initiative to understand the international advanced quality management concepts,move closer to the international level and international standards,and improve the overall level of China's sterile medicinal products manufacture industry.