Annex 1 2008 is the basis for the 2022 version. This paper provides an easy-to-understand side by side comparison of the Annex 1 2008 v. 2022 versions, broken down by section. In August 2022, a new revision of the EU GMP Annex 1 regulatory standard for sterile drug products was release...
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。 应用> 为什么修订欧盟GMP附录1?
Introduction: The EU Rules for Manufacture of Medicinal Products GMP, published in 1989, contained an annex on the manufacture of sterile medicinal products to assure the sterility of medicinal products. A version of this annex, "Annex 1", issued according to its document history in May 2003, ...