EU-GMP Chapter 4 Revision: When Photos, Video and Real-Time Feeds Become GMP Records

Executive Summary

For most of the last decade, the photos your team snapped of a deviation, the video from a cleanroom camera, and the footage in a training file sat in a grey zone. They were useful, but few sites treated them as formal GMP records. That is changing. The European Medicines Agency (EMA) published a draft revision of EU-GMP Chapter 4 (Documentation) on 7 July 2025, with the public consultation closing on 7 October 2025 and final adoption expected in mid-2026. The new draft is format-neutral. It defines a record by what it proves, not by whether it is printed on paper. That means audio, video and image records now fall squarely inside the scope of good documentation practice, and the same data-integrity rules you apply to a batch record apply to them too.

This article explains what the revised Chapter 4 says, why it matters for pharmaceutical and EU-GMP cannabis sites, and the practical steps quality and data-integrity leads should take now. It also shows where Chapter 4 connects to the parallel revisions of Annex 11 (Computerised Systems) and the brand-new Annex 22 (Artificial Intelligence), the other two parts of the EMA's 2026 GMP package.

Introduction

Walk through almost any modern GMP facility and you will find cameras, screens and image capture everywhere. Real-time video watches aseptic filling lines. Operators photograph broken vials, label defects and equipment set-ups on validated tablets. Training is recorded so it can be reviewed and reused. Visual inspection systems generate thousands of images a shift. All of this output tells a story about what happened, when, and whether the process stayed in control.

Until now, the EU-GMP guide did not say much about any of it. Chapter 4 was written in 2011, when documentation still meant paper and the occasional spreadsheet. The 2025 draft accepts that the world has moved on. It rebuilds the chapter around data governance, risk and ALCOA++, and it makes one quiet but far-reaching change: it stops treating documentation as something that lives only on a page. If a photo, a video clip or a live feed is used to make or support a GMP decision, it is a record, and it has to be controlled like one.

For QA managers, data-integrity leads and computerised-systems owners, that raises an uncomfortable question. How many of the images and video your site generates every day are actually under control? This is the gap the revised Chapter 4 is designed to close.

What Is the EU-GMP Chapter 4 Revision?

In short: Chapter 4 is the part of the EU-GMP guide (EudraLex Volume 4) that sets the rules for documentation. The 2025 draft is a major rewrite that expands the definition of a GMP record to cover all formats, including audio, video and images, and ties them to formal data-integrity controls.

The EMA's GMP/GDP Inspectors Working Group, together with the Pharmaceutical Inspection Co-operation Scheme (PIC/S), drafted the revision. The document has grown from roughly nine pages to seventeen, and around half of it has been rewritten. The chapter now governs documentation regardless of whether it is kept on paper, electronically, or in a hybrid mix of both.

Three features stand out:

• A data governance system runs through the whole chapter (sections 4.10 to 4.18 in the draft), covering data from creation through to retirement, built on risk and clear ownership.
• ALCOA++ is formally written into the guidance. The principles are Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available and Traceable.
• The definition of records is expanded to state that records include the raw data used to generate other records. That single sentence pulls a lot of previously informal material, including visual media, into scope.

The draft also introduces the Validation Master Plan as a recognised master document and sharpens the language around specifications, SOPs and technical and quality agreements. But for sites with cameras and image capture, the headline is the move to a format-neutral definition of a record.

Why Does This Matter Now?

In short: Chapter 4 is not arriving alone. It is one of three linked 2026 GMP updates, and together they raise the bar for how every kind of record, including visual media, is governed and inspected.

On 7 July 2025 the EMA released three drafts at once:

• Chapter 4 (Documentation), revised.
• Annex 11 (Computerised Systems), revised.
• Annex 22 (Artificial Intelligence), brand new.

The consultation ran until 7 October 2025, and the final versions are expected around mid-2026, almost certainly followed by a transition period before compliance becomes mandatory. The three documents were written to work as a set. Chapter 4 defines what a record is and how it must behave. Annex 11 governs the computerised systems that create and store those records, with stronger expectations for audit trails, validation and supplier oversight. Annex 22 sets the first EU rules for using artificial intelligence and machine learning in GMP, including image-based systems that classify defects or inspect product.

This is why visual media can no longer sit in a grey zone. A cleanroom video stored on a network drive, a defect photo on a validated tablet, and an AI vision system that grades tablets are all touched by at least one of these three documents, and often all three. Sites that wait for the final text risk discovering, during their first inspection under the new rules, that a large body of their day-to-day evidence was never controlled to GMP standards.

What Counts as a GMP Record Under Chapter 4?

In short: Under the revised Chapter 4, a record is anything that provides evidence of a GMP activity or that is used to generate another record, in any format. If a photo, video or audio file is relied on to make or defend a quality decision, it is a GMP record.

The 2011 text described records as evidence of various actions taken to demonstrate compliance with instructions. The 2025 draft keeps that idea and adds the crucial line that records include the raw data used to generate other records. Read alongside the chapter's repeated insistence that the rules apply to paper, electronic and hybrid formats alike, the message is clear. Format does not decide whether something is a record. Function does.

That brings a wide range of media into scope. The table below shows common examples and how each is typically treated today versus what the revised Chapter 4 expects.

The practical test is simple. Ask whether anyone would point to that file to prove a process was done correctly, to support an investigation, or to release a batch. If the answer is yes, it is a record, and it needs the same controls as any other GMP document.

How Does This Affect Data Integrity and Compliance?

In short: Every visual or audio record now has to meet ALCOA++. That means it must be attributable, original, contemporaneous, complete and traceable, with controls over who can capture, edit, store and delete it.

Applying ALCOA++ to a paragraph in a batch record is well understood. Applying it to a video file or a folder of inspection images is where many sites will find gaps. The principles do not change, but the implementation does.

Attributable. You must be able to show who captured the image or video and when. A photo with no operator identity and no reliable timestamp fails this test. Capture devices should record user and time automatically wherever possible.

Original and Accurate. The first capture must be preserved. Pasting a low-resolution screenshot into a Word report and deleting the source file destroys the original. The native file, with its metadata, is the record. Any annotated copy is a secondary record that must be linked back to the original.

Contemporaneous. The capture time has to be reliable and synchronised. Cameras and tablets with unverified or editable clocks are a common weak point.

Complete and Consistent. Selective capture is a serious risk. If an operator photographs only the acceptable results and not the failures, the record is neither complete nor honest. Procedures should define what must be captured, not leave it to discretion.

Enduring and Available. Video and image files are large. Sites need storage that lasts through the full retention period and a way to retrieve and play back the media years later, including the codec or viewer needed to open it.

Traceable. Any change, including cropping, compression or re-encoding, should be captured in an audit trail. Media that can be edited with no record of the change is a data-integrity finding waiting to happen.

The most common weakness, in our experience supporting sites through inspections, is the orphaned media file: a photo or clip that influenced a decision but lives outside any controlled system, with no audit trail, no defined retention and no owner. Inspectors are increasingly trained to look for exactly this kind of uncontrolled evidence.

Compliance Checklist: Are Your Visual and Media Records GMP-Controlled?

Use this checklist to test your readiness before the final Chapter 4 text lands.

• You have identified every source of audio, video and image data on site, including cameras, tablets, inspection systems and mobile devices.
• Each media source is classified as either a GMP record or not, with a documented rationale.
• Capture devices automatically record user identity and a synchronised, reliable timestamp.
• Original media files are preserved, not just screenshots or pasted copies.
• Media records are stored in a system with access controls and an audit trail.
• Retention periods for visual and audio records are defined and match other GMP records.
• You can retrieve and play back archived media for the full retention period, including the required viewer or codec.
• Procedures define what must be captured, so capture is complete rather than selective.
• Any AI or machine-vision system that uses images is identified and assessed against draft Annex 22.
• Service providers and cloud platforms that host your media are under a quality or technical agreement with defined responsibilities.
• A data governance owner is accountable for visual and media records across their lifecycle.

Common Mistakes Sites Make

Treating cameras as security tools only. Many sites run cleanroom and line cameras under facilities or security, entirely separate from quality. If that footage is ever used to confirm a GMP activity, it has quietly become a record under uncontrolled conditions.

Keeping the screenshot, deleting the source. Copying an image into a report and discarding the native file is one of the fastest ways to lose the original and its metadata. Inspectors notice when the only evidence is a compressed picture inside a document.

Editable clocks and shared logins. A tablet where the date can be changed, or a shared camera account with no individual attribution, undermines both contemporaneousness and attributability.

No retention plan for large files. Sites set retention for paper and electronic batch records but forget that a year of cleanroom video is enormous. Without a storage and retrieval plan, media either gets deleted early or becomes unreadable.

Forgetting the AI angle. Image-based inspection and classification systems are increasingly common. Under the 2026 package, those systems sit at the intersection of Chapter 4, Annex 11 and Annex 22, and need validation, explainability and human oversight, not just a vendor's word that they work.

Leaving service providers out of scope. When media is stored or processed by a cloud provider, the revised guidance expects clear, written allocation of responsibilities and periodic review of that provider.

How Chapter 4 Connects to Annex 11 and Annex 22

Chapter 4 sets the principle that a record is a record in any format. Annex 11 and Annex 22 supply the technical controls.

Annex 11 (Computerised Systems) is being raised to a full lifecycle standard, with stronger requirements for audit trails that are secure and reviewable, clearly defined user requirements, periodic reviews, and explicit oversight of suppliers and cloud or software-as-a-service environments. If your video or image records live in a computerised system, that system has to meet Annex 11.

Annex 22 (Artificial Intelligence) is the first EU-GMP guidance written specifically for AI and machine learning. Early drafts focus on static, deterministic models and expect clearly defined intended use, validation against pre-set acceptance criteria, explainable decision logic, ongoing performance monitoring and a human in the loop for final decisions. An AI system that inspects product images falls here.

Read together, the three documents close the loop. Chapter 4 says the image is a record. Annex 11 governs the system that holds it. Annex 22 governs any AI that interprets it. A site that prepares for one but ignores the others will still have gaps.

What Should Companies Do Now?

The final text is not yet law, but the direction is settled and the smart move is to prepare during the run-up to mid-2026 rather than after.

Start with discovery. Map every source of audio, video and image data on site. Most quality teams are surprised by how many they find once they look beyond the document management system.

Next, classify. For each source, decide whether its output is a GMP record and write down why. This single exercise often surfaces the orphaned media that creates the most risk.

Then close the gaps. Bring in-scope media into controlled systems with attribution, audit trails, retention and access control. Update SOPs so capture is complete and consistent. Put service providers and AI systems under proper agreements and assessments.

Finally, build it into your data governance model so visual and media records have a clear owner and a defined lifecycle, exactly like every other GMP record. A focused data-integrity gap analysis is usually the fastest way to see where you stand.

How MFLRC Can Help

At MF License & Regulatory Consultants (MFLRC), we help pharmaceutical and EU-GMP cannabis sites turn regulatory change into practical, inspection-ready systems. The Chapter 4 revision sits right in the middle of two of our core disciplines: quality assurance, and audit and gap assessment.

We can support your site with:

• Data-integrity gap analysis focused on your audio, video and image records, mapping every source against ALCOA++ and the revised Chapter 4 expectations. This pairs naturally with our quality assurance and compliance support.
• SOP development for capturing, storing, retaining and reviewing visual and media records, so capture is complete and defensible.
• Computerised systems and data governance review, aligning your systems with the revised Annex 11 and the principles in pharmaceutical quality assurance.
• AI and machine-vision readiness for image-based inspection systems under draft Annex 22.
• Inspection-readiness and mock audits, including a focused review against the four core types of quality assurance and sector checklists such as our cannabis QA compliance checklist.
• Licensing and dossier support, making sure your evidence holds up where it matters, as explained in what a dossier is and why it matters.

Led by Mussarat Fatima, with more than twenty years in quality assurance, quality control and regulatory affairs across pharmaceutical, food and cannabis sectors, our team gives you senior, defensible advice rather than a generic checklist.

Need help getting your visual and media records GMP-ready before the 2026 Chapter 4 update? Contact MFLRC for expert guidance tailored to your site.

Frequently Asked Questions

When does the revised EU-GMP Chapter 4 take effect?

The draft was published on 7 July 2025 and the consultation closed on 7 October 2025. The final version is expected around mid-2026, likely with a transition period before compliance becomes mandatory. The exact dates will be confirmed when the EMA publishes the final text.

Are photos and video really considered GMP records now?

Yes, where they provide evidence of a GMP activity or are used to generate another record. The revised Chapter 4 is format-neutral, so a photo, video or audio file relied on for a quality decision is a record and must meet the same data-integrity controls as any other document.

What is ALCOA++ and how does it apply to video and images?

ALCOA++ stands for Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available and Traceable. For visual media it means knowing who captured the file and when, preserving the original with its metadata, storing it securely with an audit trail, and keeping it readable for the full retention period.

Does this apply to EU-GMP cannabis sites as well as pharma?

Yes. Any site operating to EU-GMP, including cannabis sites producing for the EU market, falls under the same documentation and data-integrity expectations. Visual monitoring and image capture are common in cannabis cultivation and processing, so the impact is significant.

How is Chapter 4 related to Annex 11 and Annex 22?

They are the three parts of the EMA's 2026 GMP update. Chapter 4 defines what a record is, Annex 11 governs the computerised systems that hold records, and the new Annex 22 sets rules for artificial intelligence, including image-based inspection. They are designed to be read together.

What is the single most important step to take now?

Map and classify every source of audio, video and image data on your site, then decide which outputs are GMP records. This usually reveals the uncontrolled orphaned media that carries the most inspection risk, and it sets the foundation for everything else.

Conclusion

The revised EU-GMP Chapter 4 does not invent new technology. It catches the guidance up with technology that GMP sites have used for years. By defining a record by its function rather than its format, the EMA has brought photos, video and real-time feeds into the heart of good documentation practice. Combined with the revised Annex 11 and the new Annex 22, the 2026 package signals a clear shift from procedural paperwork to governed, traceable, inspection-ready data in every form.

For QA and data-integrity leads, the work is identifiable and finite. Find the media, classify it, control it, and govern it. Sites that start now will meet the 2026 deadline with confidence. Those that wait may find that years of valuable evidence were never controlled to the standard inspectors now expect.

Sources and References

• European Commission - Stakeholders' Consultation on EudraLex Volume 4: Chapter 4, Annex 11 and New Annex 22. View source
• EudraLex Volume 4 - Good Manufacturing Practice guidelines, European Commission. View source
• PIC/S - Joint stakeholders' consultation on the revision of Chapter 4, Annex 11 and Annex 22. View source
• ECA Academy - Drafts of EU GMP Guideline Annex 11, Annex 22 and Chapter 4 released for comment. View source

This article is intended for general guidance and reflects the draft EU-GMP Chapter 4, Annex 11 and Annex 22 as published for consultation in July 2025. The draft text and timelines may change before final adoption. Confirm current requirements against the published EMA and European Commission guidance before making compliance decisions.