Artificial intelligence in pharmaceutical manufacturing is increasingly becoming not only a guidance-development topic but also an inspection capability topic.
From 15 to 17 September 2026, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will hold its PMDA-ATC GMP Inspection Seminar 2026 in Tokyo.
The seminar is intended exclusively for regulators involved in pharmaceutical GMP inspections.
One of its primary objectives is explicit:
to build a shared understanding of the draft PIC/S GMP Annex 22 on Artificial Intelligence.
The event is aligned with the PIC/S training programme and is also described as a pre-learning opportunity for the 2026 PIC/S Seminar in Istanbul.
For pharmaceutical manufacturers, the event does not introduce a new GMP requirement.
However, it provides an important signal about where international inspector attention is moving.
Annex 22 Is Becoming an Inspector Training Topic
Until recently, much of the discussion around AI in GMP focused on:
- drafting regulatory guidance;
- public consultation;
- industry comments;
- regulatory workshops;
- interpretation of existing computerized-system requirements.
The PMDA seminar represents another stage:
training inspectors to understand the technology and discuss how it should be approached during GMP oversight.
According to PMDA, the seminar aims to create shared understanding among participating regulators through discussion of:
- the draft PIC/S GMP Annex 22;
- advanced technologies in pharmaceutical manufacturing;
- GMP inspection approaches;
- inspection reliance in Asia.
This is significant because implementation of any new GMP expectation ultimately depends not only on the wording of guidance but also on how inspectors interpret and apply it.
The Seminar Is for Experienced GMP Inspectors
The audience is deliberately restricted.
PMDA specifies that participants should be regulatory authority personnel with substantial practical inspection experience.
The criteria include inspectors who have:
- significant on-site GMP inspection experience;
- more than three years of work in GMP regulatory activities;
- intermediate knowledge of GMP regulations.
Approximately 30 regulators are expected to participate.
This is therefore not a general educational webinar about artificial intelligence.
It is a focused GMP inspector capacity-building activity.
Why This Matters for Pharmaceutical Companies
The event itself does not change the legal status of Annex 22.
The Annex remains a draft.
Nevertheless, companies should distinguish between two questions:
Is Annex 22 already an enforceable GMP requirement?
No.
and:
Are GMP inspectorates already developing knowledge and inspection capability around AI?
Clearly yes.
That distinction is important.
Waiting until the final Annex 22 becomes formally effective before establishing any AI governance could leave organisations behind the regulatory learning curve.
Companies already using AI in GMP-relevant processes should therefore be able to explain:
- where AI is being used;
- what its intended use is;
- what its GxP impact is;
- how the system was evaluated;
- what data it depends on;
- how its performance is controlled;
- what human oversight exists;
- how changes are managed;
- how ongoing performance is monitored.
These are not presented here as new requirements created by the PMDA seminar.
They are sensible readiness questions arising from the broader lifecycle-control approach already visible in draft Annex 22 and international AI regulatory discussions.
From Regulatory Text to Regulatory Capability
There are several stages in the development of a new regulatory expectation.
A simplified sequence could be:
Regulatory Discussion
↓
Draft Guidance
↓
Public Consultation
↓
Regulator and Industry Workshops
↓
Inspector Training and Harmonisation
↓
Final Guidance
↓
Inspection Experience
The PMDA-ATC seminar is important because it sits in the middle of this transition.
It shows that regulatory authorities are not only discussing what AI guidance should say.
They are also developing the capability necessary to understand AI during future GMP oversight.
PIC/S Alignment Makes the Event More Significant
PMDA describes the seminar as aligned with the PIC/S training framework.
PIC/S separately lists the PMDA event and confirms that its programme will focus on:
- the draft PIC/S GMP Annex 22 on Artificial Intelligence;
- advanced technologies in pharmaceutical manufacturing;
- GMP inspection reliance.
This matters because PIC/S provides an important international platform for harmonisation of pharmaceutical inspection practices.
The value of Annex 22 therefore potentially extends beyond the European Union.
A common inspector understanding of AI could influence GMP expectations across multiple PIC/S participating authorities.
For multinational pharmaceutical companies, this could gradually reduce the possibility of treating AI governance as an isolated EU compliance topic.
AI Governance May Become Part of Inspection Readiness
Historically, inspection-readiness programmes typically focus on topics such as:
- quality systems;
- data integrity;
- validation;
- deviations and CAPA;
- change control;
- computerized systems;
- process validation;
- supplier management.
As AI becomes embedded in these processes, a new layer may emerge.
Inspectors may increasingly need to understand whether AI is involved when reviewing:
- GMP documentation;
- deviation investigations;
- CAPA proposals;
- quality trending;
- process monitoring;
- predictive maintenance;
- laboratory activities;
- manufacturing control;
- decision-support systems.
This does not necessarily mean that inspectors will begin conducting separate “AI inspections”.
More likely, AI governance will become part of existing GMP system inspection whenever AI materially affects the regulated activity.
An AI Inventory Becomes Increasingly Important
One practical implication is particularly straightforward.
A company cannot adequately govern AI if it does not know where AI is being used.
A useful first step is therefore a controlled inventory covering:
- AI system or model;
- system owner;
- intended use;
- GxP relevance;
- supplier;
- model type;
- data sources;
- validation status;
- human oversight;
- change-management approach;
- performance monitoring.
This becomes even more important when AI functionality is embedded inside existing commercial software and may not initially be recognised as a separate AI application.
Do Not Confuse Training Activity with a New Requirement
It is equally important not to overinterpret the PMDA event.
The seminar:
- does not make draft Annex 22 effective;
- does not create a new Japanese GMP requirement;
- does not demonstrate that every participating regulator will interpret Annex 22 identically;
- does not establish an implementation date.
Its importance lies elsewhere.
It demonstrates that experienced inspectors are already being prepared to understand and discuss AI in pharmaceutical manufacturing.
That is a meaningful regulatory signal even before the final Annex is published.
What Pharma Should Watch Next
Several developments will now be particularly important:
- the finalisation of EU GMP Annex 22;
- any changes to the treatment of Generative AI and probabilistic models;
- the relationship between Annex 22 and revised Annex 11;
- PIC/S adoption and implementation;
- future inspector training materials;
- early inspection experience involving AI-enabled systems.
The most valuable evidence will eventually come not only from the final wording of Annex 22 but from how regulators apply it in practice.
Why This Development Is Important
The pharmaceutical AI discussion is entering a new phase.
The question is moving from:
“Should GMP regulators develop requirements for AI?”
towards:
“How should inspectors evaluate AI when they encounter it in pharmaceutical manufacturing?”
The PMDA/PIC/S training activity suggests that regulatory authorities are beginning to prepare for that second question.
For pharmaceutical companies, this is a good reason to begin treating AI governance as part of routine GMP inspection readiness rather than as a future digital-transformation issue.
Regulatory Status Note
The PMDA-ATC GMP Inspection Seminar is a regulator training and capacity-building activity.
Draft PIC/S/EU GMP Annex 22 remains under development and is not currently an effective GMP requirement.
The observations above concerning inspection readiness are therefore an interpretation of the regulatory direction and should not be read as new formal requirements arising from the seminar.
Sources
PMDA – PMDA-ATC GMP Inspection Seminar 2026:
https://www.pmda.go. … h/symposia/0351.html
PIC/S – Meetings and Training Events: