EU GMP Chapter 4: Documentation (2011)

Context and history

Chapter 4 is the part of the EU GMP Guide on documentation, and good documentation is one of the foundations of GMP. This version is revision 1, with a deadline of 30 June 2011 for coming into operation, the same date as Annex 11. The Commission revised the sections on generating, controlling and retaining documents because electronic documents were becoming more common.

It is often overlooked in computerised systems work, but it matters: Annex 11 explains how systems should behave, and Chapter 4 explains what records you must have and how long to keep them. A revised Chapter 4 went out for consultation in July 2025. This version applies until that is published and comes into operation.

Who and what it applies to

Holders of manufacturing authorisations for medicinal products for human and veterinary use. It covers all GMP documents and records, in any form, including paper, electronic and photographic media.

What it contains

Principle

Good documentation is essential to quality assurance. Document types and media should be defined in the quality management system, and there are two main types: instructions and records or reports.

Required GMP documentation

Lists the types: site master file, instructions such as specifications, manufacturing formulae, processing and packaging instructions, procedures, protocols and technical agreements, and records or reports such as batch records, certificates of analysis and reports.

Generation and control

All types of document should be defined and followed. Many documents can exist in hybrid forms, and the relationships and control measures for master, official copy and data handling should be stated.

Good documentation practices

Handwritten entries should be clear, legible and indelible, made at the time of action, and alterations signed, dated and leaving the original readable, with a reason where appropriate.

Retention of documents

States which record relates to which activity, and where it is kept. Batch documentation is kept for one year after expiry of the batch, or five years after certification by the Qualified Person if longer. Critical supporting documents have their own expectations.

Specifications

Requirements for starting and packaging materials, intermediate, bulk and finished products.

Manufacturing formula and processing instructions

What approved formulae, processing and packaging instructions must contain.

Procedures and records

Receipt, sampling, testing and other procedures and records, plus an inventory of documents in the quality management system.

Key points

• Documents can be on paper, electronic or photographic, and the same principles apply to all of them.
• Suitable controls must ensure the accuracy, integrity, availability and legibility of documents.
• Handwritten corrections must leave the original visible, and should give a reason where appropriate.
• Records must be made at the time each action is taken.
• Batch documentation has a defined minimum retention period.
• Keep an inventory of documents in the quality management system.

In practice

General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.

• Define hybrid records clearly: state which is the master, the paper or the electronic record, and how they are linked.
• Check that retention in your electronic systems matches your retention schedule, and survives system changes.
• Read Chapter 4 alongside Annex 11 when designing records in any new system.
• Train staff on correction practice, a common inspection finding on paper records.

Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.