111 ANNEX11 COMPUTERISEDSYSTEMS Principle Theintroductionofcomputerisedsystemsintosystemsofmanufacturing,including storage,distributionandqualitycontroldoesnotaltertheneedtoobservetherelevant principlesgivenelsewhereintheGuide.Whereacomputerisedsystemreplacesamanual operation,thereshouldbenoresultantdecreaseinproductqualityor...
Annex 1 Manufacture of Sterile Medicinal Products Annex 2 Manufacture of Biological Medicinal Products for Human Use Annex 3 Manufacture of Radiopharmaceuticals Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products Annex 5 Manufacture of Immunological Veterinar...
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, facilitatin...
1 介绍与相关法令 Introduction EudraLex - Volume 4 (europa.eu)1.1 介绍 Introducti...
How are the data integrity expectations (ALCOA) for the pharmaceutical industry prescribed in the existing EU GMP relating to active substances and dosage forms published in Eudralex volume 4? 在Eudralex第4卷公布的与活性物质和剂型有关的现有欧盟GMP中,如何规定制药业的数据完整性期望(ALCOA)? 关注...
Volume 4 of 'The rules governing medicinal products in the European Union' contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directiv...
作者: ANNEX 摘要: EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 14 February 2008 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary ...
Volume 4 of 'The rules governing medicinal products in the European Union' contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directiv...