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...
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
The guidance shares a similar flow and organization with the EU EudraLex Volume 4 Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. Since the publishing of Volume 4 there has been an evolution of technology and deeper understanding by the regulators. Scope Of...
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 ...
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...
5、of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology.变更原因:附录 15至 2001年颁布以来,制造业和法规环境发生了显著变化,因此需要更新附录以反应这些环境的变化,附录15的修...