Chapter 4 (2011) and its 2 linked instruments
How to read this page
- First column: Chapter 4 (2011). The others are every document linked to it.
- Scroll sideways if there are more columns than fit.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
| Chapter 4 (2011) | Chapter 4 revision | Annex 11 (2011) | |
|---|---|---|---|
| Authority | European Commission | European Commission | European Commission |
| Legal weight | GMP guide & annexes | GMP guide & annexes | GMP guide & annexes |
| Status | In force | Draft | In force |
| Last verified | Not yet | Not yet | Not yet |
| Summary | The current EU GMP chapter on documentation. Manufacturers of medicinal products must define their documents and media in the quality management system, on paper, electronically or as photographs, and keep them accurate, intact, available and legible. Revision 1 updated the sections on generating, controlling and retaining documents because of growing electronic use. | Revised GMP documentation chapter, consulted on jointly with PIC/S. It updates expectations for records in any format, data governance and the documentation lifecycle, aligning with the revised Annex 11. Draft only. | The current EU GMP annex for computerised systems used in GMP-regulated activities. It covers risk management, validation, data, audit trails, security, electronic signatures, periodic evaluation and business continuity. It stays in force until the revised Annex 11 is published and comes into operation. |
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| Source | Official text Source: European Commission. Licensed under CC BY 4.0. | Official text Source: European Commission. Licensed under CC BY 4.0. | Official text Source: European Commission. Licensed under CC BY 4.0. |
These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.