Compare Chapter 4 revision and Chapter 4 (2011)
How to read this page
- How they are linked says why these two documents are connected. Links explained
- Side by side places facts from each record together, so you can see status, weight and dates at a glance.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
How they are linked
- Chapter 4 revision will replace Chapter 4 (2011) · Source Unverified link
Clause crosswalk: EU GMP Chapter 4 (2011) ↔ Chapter 4 revision (draft)
Side by side
| Chapter 4 revision | Chapter 4 (2011) | |
|---|---|---|
| Authority | European Commission | European Commission |
| Legal weight | GMP guide & annexes | GMP guide & annexes |
| Status | Draft | In force |
| Last verified | Not yet | Not yet |
| Summary | 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 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. |
| Lifecycle |
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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. |
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.