In July 2025, the European Commission published the draft revision of Chapter 4, Documentation, of the EU GMP Guidelines, as part of a coordinated update that also includes the revision of Annex 11 and the new Annex 22 on Artificial Intelligence. The public consultation opened on 7 July 2025 and closed on 7 October 2025.
The proposal represents a significant change in the way GMP documentation is understood and managed. The concept of documentation is more clearly integrated with data governance, data integrity and risk management, with particular attention to an increasingly digitalised environment in which paper documents, electronic records, hybrid solutions and external services coexist.
The draft expands the traditional approach to document control to address GMP documentation and data from a comprehensive lifecycle perspective, regardless of their format or medium.
This approach more clearly integrates documentation management into the Pharmaceutical Quality System (PQS) and strengthens its relationship with other GMP requirements, particularly those applicable to computerised systems. The draft has been developed in coordination with the revision of Annex 11.
What changes with the revision of Chapter 4?
1. Data Governance
Data governance takes on a central role in GMP documentation management. The aim is to establish a framework that ensures information is properly managed throughout its entire lifecycle.
Risk management principles are integrated into this governance system to ensure the accuracy, integrity, availability and legibility of documentation, regardless of the format used.
2. Risk Management
Risk management takes on greater importance and becomes an explicit part of the data governance approach.
Controls applied to documentation and data must be designed with consideration for the associated risks and the need to adequately preserve GMP information.
3. Data Integrity
Although data integrity is not a new concept within the GMP framework, the requirements relating to electronic records management and data integrity are addressed more explicitly.
The focus is therefore not solely on controlling documents, but also on ensuring the integrity and reliability of the information they contain.
4. Hybrid Systems
The revision pays particular attention to hybrid solutions, namely environments in which documentary components coexist in different formats or media.
This is particularly relevant for organisations where certain GMP processes combine paper documentation with electronic records. In these cases, it is necessary to ensure the integrity, availability and legibility of documentation, regardless of the medium used.
5. Electronic Signatures and Records
The proposal also clarifies the requirements relating to the management of electronic records and signatures, in alignment with the simultaneous revision of Annex 11.
In practice, this makes the connection between document control and the controls applied to computerised systems that generate, process or retain GMP information even more important.
6. A Broader Definition of Documentation
Another significant change is the adaptation of the concept of documentation to today’s technological environment.
The European Commission explicitly states that documentation may take the form of text, images, video or audio, and establishes the principle that it must remain complete and legible throughout its entire lifecycle.
The concept of GMP documentation is therefore expanded to accommodate the variety of formats in which regulated information can currently be generated and retained.
7. Greater Adaptation to the Digital Environment
Overall, the revision aims to facilitate the use of new technologies, hybrid solutions and new services in documentation management, while maintaining the principles required to ensure information quality and integrity.
New Elements in the Structure of Chapter 4
The new structure reflects this change in approach. Key additions include sections specifically dedicated to Data Governance Systems (2), Risk Management (3), Signatures (8), Data Integrity in Documentation (10) and Hybrid Systems (11).
Other sections reorganise or further develop documentary aspects already covered in the previous version, adapting them to the new technological context and the strengthened approach to data lifecycle management.
What Could This Mean for the Pharmaceutical Industry?
If the proposed approach is retained, pharmaceutical companies will need to consider documentation, data, computerised systems and risk management in a more integrated way.
The main areas of impact would include:
1. Data Governance and Integration into the PQS
Companies will need to assess whether their Pharmaceutical Quality System provides an adequate framework for managing GMP documentation and data throughout their entire lifecycle, with clearly defined responsibilities and oversight mechanisms.
2. Data Integrity and Risk Management
Controls over documentation and data will need to be addressed from a risk-based perspective, taking into account the need to preserve their accuracy, integrity, availability and legibility.
This may require a review of how risks associated with GMP information are identified and managed, and how these controls are integrated into the PQS.
3. Computerised Systems and Hybrid Documentation
Particular attention will need to be paid to processes in which computerised systems generate, process or retain GMP documentation, as well as to environments where electronic records and paper documentation coexist.
The coordinated revision of Chapter 4 and Annex 11 reinforces the relationship between these two areas and the importance of addressing them jointly.
4. Document Control, Signatures and Record Retention
Procedures for generating, reviewing, approving, signing, archiving and retaining documentation will need to be assessed from a lifecycle perspective, considering both traditional documents and electronic records, as well as other information formats covered by the draft.
From Document Management to Information Governance
Ultimately, the revision of Chapter 4 reflects a shift in the way GMP documentation is understood. The focus is no longer limited to the formal control of documents, but extends to the information they contain and how it is managed throughout its entire lifecycle.
For the pharmaceutical industry, this may require a review not only of documentation procedures, but also of their relationship with computerised systems, risk management and the governance mechanisms established within the PQS.
Ultimately, the proposed evolution can be summed up as a shift in perspective: moving from document control to the governance of GMP information that underpins quality decisions.
