Annex 10Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation Annex 11Computerised Systems (revision January 2011) Annex 12Use of Ionising Radiation in the Manufacture of Medicinal Products Annex 13Manufacture of Investigational Medicinal Products ...
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...
The main regulatory expectation for data integrity is to comply with the requirement of ALCOA principles. The table below provide for each ALCOA principle the link to EU GMP references (Part I, Part II and Annex 11): 对数据完整性的主要监管期望是遵守ALCOA原则的要求。下表为每项ALCOA原则提供了...
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...