3.2 All non-conformities, such as sterility test failures, environmental monitoring excursions or deviations from established procedures should be adequately investigated before certification/release of the batch. The investigation should determine the potential impact upon process and product quality and wh...
Annex 1 是2022年8月25日发布的，2023年8月25日生效。https://health.ec.europa.eu/medicinal-...
This Annex is intended to assist national authorities in the application of the EU legislation. Only the Court of Justice of the European Union is competent to authoritatively interpret Union law. 解读:说明了三种无菌产品适用于本附录,人用药、兽用药和IMP。对于无菌的IMP,无菌保证是确保临床试验安全性...
太强了，楼住极端的厚道
EudraLex第4卷《人类和兽医用药品的良好生产规范(GMP)指南》附录1为无菌药品的生产提供了指导。 监管和制造环境、科学和技术的创新使得有必要修订附件1。这些更新的指南将于2023年8月25日生效(2024年8月24日,第8.123点关于冷冻干燥机灭菌),并将影响欧盟生产的无菌药品和进口产品。
eugmpannex11计算机控制系统+eugmpannex8原辅料 和包装材料的取样 预览说明:预览图片所展示的格式为文档的源格式展示,源文件没有水印,内 容可编辑和复制 附件11 COMPUTERISEDSYSTEMS计算机控制系统 Principle原则 Theintroductionofcomputerisedsystemsintosystemsof ...
eugmpannex11计算机控制系统+eugmpannex8原辅料和包装材料的取样.pdf,附件 11 COMPUTERISED SYSTEMS 计算机控制系统 Principle 原则 The introduction of computerised systems into systems of manufacturing, including storage, distribution and quality control does n
EU GMP annex18是欧盟优良药品质量管理规范附件18的意思！
Ares(2015)1380025 - 30/03/2015EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETYMedicinal ProductsQuality, Safety and EfficacyBrussels, 30 March 2015EudraLexVolume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary Use 欧盟人 2、用及兽用药品 GMP...
灭菌药品欧洲标准EU GMP Annex I EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 25 November 2008 (rev.) EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for...