中国兽药杂志2025，Vol.59Issue(7)：15-21,7.DOI:10.11751/ISSN.1002-1280.2025.7.03
欧盟无菌药品与我国无菌兽药GMP要求的对比分析与思考
Analysis and Reflection on the GMP Requirements for Sterile Medicinal Products in the European Union and Sterile Veterinary Drugs in China
摘要
Abstract
In 2022,European Commission released a newly revised GMP annex for manufacture of sterile medicinal products,which has undergone significant changes in regulatory concepts and technical requirements,and has had a great impact on the quality management of sterile medicinal products both domestically and internationally.This article compares and analyzes the main differences in GMP requirements for sterile medicinal products in the European Union and sterile veterinary drugs in China from the aspects of overall structure,scope of application,risk management,contamination control,environmental monitoring,and personnel requirements,in order to provide useful references for improving Chinese veterinary drug GMP regulations and enhancing the management level of sterile veterinary drugs.关键词
欧盟/无菌药品/兽药/GMP/质量风险管理/污染控制策略Key words
EU/sterile medicinal products/veterinary drug/GMP/quality risk management/contamination control strategy分类
农业科技引用本文复制引用
陈莎莎,周晓翠,安洪泽,张珩,宫爱艳,吴涛..欧盟无菌药品与我国无菌兽药GMP要求的对比分析与思考[J].中国兽药杂志,2025,59(7):15-21,7.基金项目
中国兽医药品监察所兽药行业公益性重点专项"药品检查合作计划组织(PIC/S)技术标准和指南研究与国内外兽药创新和前沿技术研究"(GY202415) （PIC/S）
