欧盟与我国GMP无菌药品附录差异分析与探讨

Analysis and discussion of differences on the annex of GMP for manufacture of sterile medicinal products between China and EU

无菌药品作为高风险产品,生产过程和质量控制具有复杂性和特殊性,欧盟《人用和兽用药品生产质量管理规范指南》附录1“无菌药品生产”(欧盟GMP附录1)的发布对全球无菌药品的质量管理产生了巨大影响。为了解国际无菌药品生产质量管理的最新发展趋势与要求,把握我国无菌药品质量管理的现状,促进我国无菌药品质量提升,本文对欧盟与我国《药品生产质量管理规范(2010年修订)》附录1“无菌药品”(中国GMP附录1)的主要差异点进行了分析和探讨,为我国GMP附录1的修订和无菌药品生产企业质量提升提供参考。

As high-risk products,the production process and quality control of sterile medicinal products are complex and special,and the published EU GMP Annex 1 has had a great impact on the quality management of sterile medicinal products worldwide.This paper analyzed and discussed the main differences between EU and China GMP Annex 1,to understand the international latest development trend and requirements of quality management of sterile medicinal products,grasp the current situation of quality management of sterile medicinal products in China,promote the improvement of the quality of sterile medicinal products in China.It provide reference for the revision of GMP Annex 1 and the quality improvement of sterile medicinal products manufacturers in China.