What is EU GMP Annex 11?
Annex 11 is part of the European GMP Guidelines and defines the terms of reference for computerised systems used by organizations in the pharmaceutical industry. Annex 11 is a guideline and is key to compliance with GMP principles in EU directives (regulations) covering human and veterinary medicinal products.
What has been omitted in the new annex 11?
Therefore, there have been some changes in the new version of Annex 11 the omission of parallel testing is good and reflects current validation practice. Omitting the ability to validate systems retrospectively may catch slow companies or start-up companies moving from R&D into manufacturing for the first time.
What is the main difference between Annex 11 and 21 cfr Part 11?
While the FDA 21 CFR covers US-based pharmaceutical companies, Annex 11 is a Good Manufacturing Practice (GMP) guideline in the European Union. 21 CFR part 11 is a regulation of the FDA that applies to drug manufacturers, biotech companies and other regulated industries.
Does Annex 11 apply to medical devices?
Strictly speaking, Annex 11 applies only to medicinal products and not to medical devices. However, forward-thinking device companies may want to align their activities with the guidance.
What are EU GMP standards?
Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
What does EU GMP certified mean?
European Union Good Manufacturing Practices
EU GMP certification is the highest recognition available by companies in the pharmaceutical space. European Union Good Manufacturing Practices details the production, handling, storage and packaging of cannabis. The EU GMP certification is the essential piece your company will need to “go global” with Cannabis.
What is the EU equivalent of 21 CFR 11?
EU Annex 11
EU Annex 11 is the EU’s equivalent to Title 21 CFR Part 11, although it has different guidelines and regulatory practices than the latter. This guidance system mandates electronic records and signatures within the pharmaceutical industry and does not apply only to electronic documents.
What is Volume 9a in pharmacovigilance?
Volume 9 of “The rules governing medicinal products in the European Union” contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.
What is the principle of Annex 11 of the GMP?
Principle This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities. The application should be validated; IT infrastructure should be qualified.
What is the definition of computerised system in Annex 11?
This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities. The application should be validated; IT infrastructure should be qualified.
What are the annexes of EudraLex Volume 4?
Annexes Annex 1 Manufacture of Sterile Medicinal Product Annex 2 New – Manufacture of Biological active s Annex 3 Manufacture of Radiopharmaceuticals Sear Annex 4 Manufacture of Veterinary Medicinal Prod Annex 5 Manufacture of Immunological Veterinary
Where can I get the EC GMP guideline?
The following guideline can be ordered through the address listed in the “Source/Publisher”-category. In cases in which you can order through the Internet we have established a hyperlink. Supplementary guidelines to the EC-GMP Guide with specific requirements for computerized systems.