Core GMP Changes in Europe (Q4 2025)
Core GMP Changes in Europe (Q4 2025)
The European regulatory landscape has entered a phase of structural modernization. Three developments stand out.
1. EMA begins relying on FDA inspections
Since 1 October 2025, the EMA accepts FDA inspection outcomes…
Core GMP Changes in Europe (Q4 2025)
The European regulatory landscape has entered a phase of structural modernization. Three developments stand out.
1. EMA begins relying on FDA inspections
Since 1 October 2025, the EMA accepts FDA inspection outcomes for manufacturing sites outside the United States, reducing duplicate inspections and accelerating EU assessments.
2. Legally binding GMP for veterinary medicines and APIs
On 17 October 2025, the European Commission published two Implementing Regulations:
(EU) 2025/2091 — GMP for veterinary medicinal products
(EU) 2025/2154 — GMP for active substances in veterinary medicines
Both will apply from 16 July 2026, replacing previous guidance and giving the veterinary sector a dedicated, enforceable GMP framework.
https://eur-lex.europa.eu/eli/reg_impl/2025/2091/oj
https://eur-lex.europa.eu/eli/reg_impl/2025/2154/oj
3. Digital GMP: documentation, computerized systems, and AI
The EU launched a consultation to revise EudraLex Volume 4, including:
Updated Chapter 4 (Documentation)
Revised Annex 11 (Computerised Systems)
New Annex 22 (AI / Machine Learning)
The proposals introduce lifecycle data management, system validation, supplier control, and governance for AI models.
What Comes Next
In 2026–2027, three trends are likely to dominate:
Formal integration of digital compliance into EU-GMP.
The revision of Annex 11 and the introduction of Annex 22 will move GMP from “paper compliance” to continuous digital oversight, requiring validated systems, audit-ready records, and clear accountability for AI-driven decisions.
Expansion of sector-specific GMP.
The veterinary regulations are a precedent. Other domains (biologics, cell therapy, ATMPs) may gain similarly tailored GMP frameworks, clarifying responsibilities for manufacturers and supply-chain partners.
Greater transatlantic operational alignment.
EMA’s acceptance of FDA inspections signals a long-term shift. Instead of parallel audits, companies will face risk-based supervision coordinated at a regulatory level.
This will reward organizations with strong data governance, transparent quality systems, and consistent supplier control—while exposing those relying on minimal compliance.
Challenges in GMP documentation
Correct and well maintained documentation is the basis for all efficient company activities.
Requirements for the GMP documentation are described in chapter 4 of the Good Manufacturing Practice.
However, the majority of companies struggle with their documentation system, especially…
Correct and well maintained documentation is the basis for all efficient company activities.
Requirements for the GMP documentation are described in chapter 4 of the Good Manufacturing Practice.
However, the majority of companies struggle with their documentation system, especially regulatory documents.
So, what are the causes of such difficulties?
Depending on the size of the company, these difficulties can vary.
For smaller companies sometimes it's difficult to maintain the complicated documentation system and update the documents when required. Often smaller companies do not have the adequate human resources or expertise for relevant documentation. Larger companies often face other difficulties. With more personnel writing the documentation, can come a variation in style and content that can lead to disordered hierarchy and causing misunderstandings.
In addition, larger companies tend to have excessive amounts of documentation that is difficult to update.
However, certain difficulties are experienced by all companies, regardless of their size.
It’s always a difficult question to decide how detailed your documentation should be?
What level of detail is required for complete understanding?
Will those who are going to receive the instructions fully understand their meaning?
Another question, should the instructions be given in a single concise document or broken up into several? How should the instructions have complete clarity and be unambiguous?
We would like to advise you on how to overcome these problems with your documentation.
Let's discuss who should be the appropriate writer of the documentation.
What is more important - clarity or expertise?
Documentation should be written by experienced professionals with complete training for correct document writing.
An appropriate training is essential to ensure that simple and accurate language is used so as not to be misunderstood by any user.
It should be noted that experience is not a prerequisite to writing a good document, clarity in all documentation should be considered a vital area for training.
The hierarchy of the documentation is the next area for discussion.
The documentation should be classified by levels and fields.
Some documents, for example Process Descriptions, describe how the main systems are constructed. SOPs are intended to instruct personnel on how to perform their operations correctly.
All levels of documentation should be divided up into their application fields, e.g. Quality code, Manufacturing code, Technical maintenance code, etc.
If documentation writing is done by multiple personnel then errors can be done with the classification of the documentation.
Long established companies may have accumulated errors in its documentation and its classification that should be redressed through periodic audits to ensure accuracy and remove such errors.
Information included in the SOPs should be concise and relevant to the activities, they should not include excessive theoretical background which should be included in training and not be included in the SOPs.
The SOPs should contain clear and detailed instructions on how to perform activities.
However, there is always a question of how detailed they should be.
They should be detailed enough for trained personnel can perform the activities.
The personnel should be familiar with the premises, equipment and other SOPs to understand the new instruction. Personnel with the relevant training should be the only ones to act on these instructions.
It is essential that the SOPs are not over-detailed to ensure that personnel not belonging to relevant activities or manufacturing can find the documentation clear and understandable.
Language used should be relevant and clear ensuring that the documentation is not excessive or cluttered with unnecessary details.
Concise documentation is easily understood and remembered, making it simple to reference and retrieve necessary information when needed.
Well structured documentation is essential to ensure adequate business operation and record keeping.
We recommend that compulsory areas be included in documentation for essential serviceability.
If you are experiencing difficulties with your documentation system, our company would be glad to assist and work with you to access your operational systems, share professional advice and assist with documentation writing.
If you still struggling with your documentation system, our company would be glad to step in and help you with the assessment of your system, advice and documentation writing.