2020年2月20日,欧盟发布Eudralex volume 4 Annex 1《无菌药品生产》第二次征询意见,为更好地了解法规动向,我们及时对文件进行解读。今天分享给大家的是文件中第9条关于“环境监测”部分中的粒子监测,后面我们还会继续解读浮游菌监测部分 附录摘要 无菌产品的生产涉及多种产品类型(活性成分、无菌辅料、内包材和成品制...
EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 1 Manufacture of Sterile Medicinal Products (corrected version) Document History Previous version dated 30 May 2003, in ...
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
1 Annex 1 of the PIC/S GMP Guide is identical to Annex 1 of the EU GMP Guide (Eudralex Volume 4 GMP). Both Guides are equivalent in terms of GMP requirements. 2 The revision of Annex 1 to PIC/S GMP Guide was adopted on 12 November 2008 by the PIC/S Committee and entered into...
The FDA’s 21 CFR Part 11 and the EU’s EudraLex Volume 4 Annex 11 outline standards for electronic records and signatures in GMP-regulated industries. These regulations ensure that electronic documentation is as reliable and secure as paper-based systems, facilitating...
Annex 1 to EU GMP provides detailed information for the manufacture of sterile medicinal products; it supports the core chapters of EU GMP It is the first annex of EudraLex "The Rules Governing Medicinal Products in the European Union" and it forms part of Volume 4 of the Europ...
Adobe Sign合规性分析 21 CFR Part 11和Annex 11说明书 W H I T E P A P E R Adobe Sign An Analysis of Shared Responsibilities for 21 CFR Part 11 and Annex 11 Compliance
1、上海万逸医药科技有限公司刘伟强译Ref. 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 ...
annex 15 验证 201504 中英文 完 EU GMP附录15：确认和验证1/22 EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, 30 March 2015 EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice ...
21 code of federal regulations (CFR) Part 11 and Eudralex Volume 4, Annex 11 across all of the steps from the donor to acceptor site. Clear ... M Looby,C Brady,M Bentley,... - Springer, Cham 被引量: 0发表: 2024年 加载更多站...