In January 2026, the new GMP/GDP Inspectors work plan came into force EMA Working Group (GMDP IWG) for the period 2026–2028. A few months have passed and we can draw conclusions.
For years, GMP inspections have been perceived by many organizations as a one-off event: a visit, a report, a list of observations. However, the new work plan confirms something that was already intuited: inspection stops being an event and becomes a continuous supervision strategy.
This plan not only redefines inspection priorities, but also sets the course for how Europe wants to guarantee the quality, safety and resilience of its pharmaceutical supply chain until 2028, in full alignment with the European Medicines Agencies Network Strategy (EMANS) to 2028.
This article inaugurates a series of three publications dedicated to analyzing how the new European regulatory approach is redefining GMP inspections and expectations on qualification and validation. In this first installment we address the new EMA GMP inspection plan 2026–2028 and the strategic message behind it. In the next articles we will delve, first, into the review of Annex 15 and its change of focus towards a validation based on risk and life cycle, and finally into the practical impact that these changes will have on manufacturers, especially in the field of active substances (APIs). Together, these publications offer a coherent view of where GMP oversight in Europe is headed and how to proactively prepare.
1. From frequency to intelligence: truly risk-based inspections
The concept of risk-based inspections It's not new, but the new plan takes it a step further. The EMA consolidates a model in which Not all sites look the same, nor with the same intensity, but based on:
- The criticality of the manufactured medicine
- GMP Compliance History
- The technological complexity of the process
- The location and role of the site in the European supply chain
This translates into inspections more selective, deeper and better focused, where basic document preparation is no longer sufficient without a true understanding of risk by the organization.
Furthermore, the use of hybrid inspections and remote evaluations, which go from being a post-COVID temporary solution to a structural tool of the European inspection system.
2. Digitization, data integrity… and the official entry of Artificial Intelligence
One of the most disruptive elements of the 2026–2028 plan is the explicit entry of Artificial Intelligence in the GMP framework, with the development of a new Annex 22 dedicated to AI.
Along with this, the EMA foresees the in-depth review of historical pillars such as Annex 11 (Computerized Systems) and Chapter 4 (Documentation).
The message is clear: in future inspections, the data will be as important as the product. The inspectors will evaluate in greater detail:
|
Data integrity (ALCOA+ principles) |
|
Systems life cycle validation (CSV / CSA) |
|
Data governance and access control |
|
Justified and controlled use of AI algorithms or models in GMP environments |
The final texts of these updates are expected by the end of 2026, but the inspection impact is already beginning to be noticed.
3. Supply chain in focus: less implicit trust, more evidence
Another of the main lines of the plan is the strengthening supply chain protection, in an increasingly fragile and complex global context.
Future GMP inspections will pay special attention to:
- End-to-end traceability of APIs and medications
- Qualification and actual supervision of suppliers
- Management of outsourced activities
- Prevention of counterfeit medicines
The EMA has announced new specific guidelines for the assessment of risks in the authenticity of medicines, which will result in more demanding inspection expectations, especially for importers, API manufacturers and CMOs.
4. A regulatory calendar that will mark the inspection agenda
The 2026–2028 plan does not remain in general principles; establishes a clear schedule of GMP updates that will redefine inspection criteria:
With goal of completion in 2026
- Capítulo 1 – Pharmaceutical Quality System
- Chapter 4 – Documentation
- Anexo 15 – Qualification & Validation
- Annex 22 – Artificial Intelligence
- GMP Review for ATMPs
- Implementation of ICH Q12 (Lifecycle Management)
With goal of completion in 2028
- Chapter 3 – Premises & Equipment
- Chapter 5 – Production
- Capítulo 7 – Outsourced Activities
- Capítulo 9 – Self‑Inspection
- Annexes 3, 6 and 14 (radiopharmaceuticals, medicinal gases and products derived from blood/plasma)
These reviews will not be “theoretical”: will directly mark how Europe inspects in the coming years.
5. Reading between the lines: what the EMA is really telling us
Beyond lists and annexes, the new plan sends a very clear message to the industry:
It is not enough to comply; understanding, control and anticipation of risk must be demonstrated.
GMP inspections until 2028 will be less tolerant of:
- Poorly governed digital systems
- “Paper” subcontracting
- Reactive instead of proactive quality
And increasingly demanding with:
- Quality system maturity
- Ability to explain decisions
- Responsible use of innovation
Is your quality system prepared for this new inspector approach?
The EMA's GMP inspection plan until 2028 is not just a regulatory document. It is a declaration of intent on how pharmaceutical quality should evolve in Europe.
Anyone who reads it as a simple inspection schedule will be late.
Whoever understands it as a strategic guide To strengthen your GMP system, you will arrive prepared.
In the next article we will analyze one of the pillars of this change: the review of Annex 15 and what inspectors are really beginning to demand in terms of qualification and validation.