EMA publishes process guidance for GMP/GDP inspector guidance: why this matters for manufacturers and distributors

On 20 November 2025, the EMA published a document that at first glance appears “internal”: Guidance for Rapporteurs and members of drafting groups of documents developed by the GMP/GDP Inspectors Working Group. This document describes how the European GMP/GDP Inspectors Working Group (GMDP IWG) will henceforth develop and align concept papers, Q&As, reflection papers, community procedures, and amendments to the EU GMP/GDP guidelines.

For manufacturers and distributors of medicinal products, this is more relevant than it may seem. The document more clearly defines who drafts, who reviews, how broadly changes are scoped, how comments are handled, and how consistency within the guidelines is safeguarded.

The key changes in this document

The main objective of this document is to publish a visible and structured process framework for the development of guidance by inspectors. In practice, this comes down to four points that may be felt in inspections and customer/supplier audits in the coming years:

1. The guidance applies to drafting groups that develop, among other things, concept papers, (amendments to) EU GMP/GDP guideline texts, community procedures, reflection papers, and Q&As.
2. For each revision of GMP or GDP guidelines published by the European Commission, a concept paper is expected, containing at a minimum: the trigger/problem definition, objectives, impact (assessment), and timeline. This makes the route to new or tightened expectations more formal and easier for industry to follow.
3. The document explicitly states that revisions should remain “focused,” but also that the level of detail/prescriptiveness must be proportionate; overlaps and inconsistencies must be removed; cross-references must remain correct; and new terms must be defined where necessary (including impact on the GMP glossary).
4. Rapporteurs must summarise stakeholder comments in a structured way (tabulated summary) and cannot “silently” ignore them without explanation and agreement.

These are the four most important provisions, alongside smaller measures such as promoting consistency, reviewing on a legal basis, keeping entire sections up to date where changes occur, and a new role for the EMA secretariat.

Implications for the pharmaceutical industry

When guidance and Q&As are developed through a tighter process with explicit checks for inconsistencies, overlaps, and definitions, the likelihood decreases that the same situation will be considered “acceptable” in, for example, the Netherlands and a “major” deficiency in Spain.

In addition, the EMA explicitly mentions participation and alignment with inspectorates and (where relevant) PIC/S inspectors in drafting groups. For international companies, this may mean that certain interpretations converge more quickly between EU expectations and the broader inspection practices of PIC/S members.

The document also describes Q&As explicitly as a tool for harmonised interpretations of topics that often vary. For WDA holders (wholesale distribution authorisation holders), this is particularly relevant because GDP topics are often strongly practice-driven (temperature management, oversight, transport, deviations, supplier management).

View the document

View this guidance at:
https://www.ema.europa.eu/system/files/documents/other/gmp-gdp-iwg-guidance-rapporteurs-en_0.pdf