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> 服务> 为什么修订欧盟GMP...
Understand how Annex 1 2008 has been updated to Annex 1 2022 by getting this side by side comparison of the two revisions...
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, ...
21 CFR Part 11 and EU GMP Annex 11R.D. McDowallValidation in Thermal Analysis