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A guide to the EC-GMP supplementary guidelines for computerized systems in pharmaceutical manufacturing and quality control. Learn about the requirements, validation, verification, and maintenance of computerized systems.
- Revision of the EU GMP Guide Annex 11 "Computerised Systems ...
The current EU GMP Annex 11 "Computerised Systems" was...
- Revision of the EU GMP Guide Annex 11 "Computerised Systems ...
This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. It covers the validation, data integrity, risk management, personnel, suppliers and service providers, and periodic evaluation of computerised systems used as part of GMP regulated activities.
The European Medicines Agency (EMA) proposes to update Annex 11 of the Good Manufacturing Practice (GMP) guide for medicinal products, which covers computerised systems. The revision aims to address the use of new technologies, data integrity, digital transformation and other aspects of GMP.
8 paź 2003 · EudraLex Volume 4 provides guidance on the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use. Annex 11 covers computerised systems and is applicable to medicinal products for human use.
Find answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP) for human and veterinary medicines. The Q&As cover topics such as EU GMP guidelines, active substances, sterile products, outsourced activities and more.
30 lis 2022 · The current EU GMP Annex 11 "Computerised Systems" was published in 2011. Due to new technological and regulatory developments, a forthcoming revision of Annex 11 has been discussed for some time. On 16 November 2022, the EMA published a concept paper for public comment.
13 lip 2023 · EU Annex 11 is a European Union guideline that outlines the requirements for using computerized systems in GMP-regulated activities. Learn who should comply, what are the different parts, and how to comply with EU Annex 11 using SimplerQMS eQMS software.
