EU GMP Chapter 4 revision: Documentation (draft)

Context and history

This is the draft revision of the EU GMP chapter on documentation, published for consultation on 7 July 2025 with the revised Annex 11 and new Annex 22. It was jointly recommended by the GMP/GDP Inspectors Working Group and the PIC/S Committee.

It is roughly twice as long as the current chapter. The aim is to clarify regulators' expectations and reflect new technology, hybrid systems and new services. Data governance and data integrity move from background ideas to explicit requirements. It is a draft, so nothing in it applies yet, and the 2011 chapter remains in force.

Who and what it applies to

Regulated users, for GMP documentation in any format, including electronic, paper-based and hybrid systems. It extends to imagery, video and audio recordings, and to new technologies and services.

Not covered: The draft does not change requirements yet: the 2011 chapter still applies.

What it contains

Principle

Documentation is essential to the quality system, whatever technology is used. A risk-based approach within a data governance system is pivotal for scaling integrity controls.

Data governance systems

Regulated users should establish a data governance system for the media they use.

Risk management

Applies quality risk management to documentation and data.

General requirements for documentation

Covers master documents and what must be documented.

Generation and control of documentation

How documents are created, reviewed, approved and controlled.

Good documentation practice

Expectations for entries and corrections, including that hand-written instructions are discouraged.

Signatures in GMP relevant documentation

Requirements for signatures on GMP documents.

Retention of documents

How long records are kept.

Data integrity in documentation

Explicit data integrity expectations.

Hybrid systems

Expectations when paper and electronic records are used together.

Glossary

Defined terms.

Key points

• Data governance becomes an explicit requirement.
• The rules apply regardless of technology or service.
• Regulated users must determine which legal provisions apply, considering new technologies and hybrid solutions.
• Hybrid systems get their own section.
• Signatures get specific attention.
• Read it with draft Annex 11, as they were written together.
• Nothing here applies until the final text is published and in operation.

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.

• If you have no written data governance system, the draft is a good reason to start one, whatever the final text says.
• List where you run hybrid records, as these look set to get closer attention.
• Review how you handle video, audio and image records, which the draft brings clearly into scope.
• Do not rewrite procedures for a draft, but plan the work.

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.