https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
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 ...
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...
One of the major discussion points during the industry review of the draft Annex 2A guidance in 2019 was around what portions of the ATMP process fall under this guidance. Volume 4 describes a risk-based approach, and the FDA has issued guidance documents targeting clarification of what falls u...
16. The pr ocedur es t o be followed if t he syst em fails or br eaks down should be defined and validat ed. Any failur es and r emedial act ion t aken should be r ecor ded. 17. A pr ocedur e should be est ablished t o r ecor d and analyse er r or s and t o ...
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...
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...