Questions and Answers from the ECA Webinar "GDP Update 2026" - Part 4

Around 120 participants attended the ECA Webinar “GDP Update 2026” on 12 March 2026. The aim of this two-and-a-half-hour session was to provide participants with a comprehensive overview of current developments and key updates in the field of Good Distribution Practice (GDP).

The webinar was divided into a regulatory and an operational part. The following topics were addressed:

• ZLG (Germany) – GDP for active substances in Germany
• MHRA (UK) –  Requirements for sea and air transport
• Swissmedic (Switzerland) – When to report changes to authorities?; Guideline on the return of medicinal products; Requirements for supply chain traceability
• HPRA (Ireland) – Update GDP Guidance
• FDA/USP (USA) – Implementation of DSCSA; Temperature mapping & transport validation; Use of Mean Kinetic Temperature
• EMA/ECA – GDPA: Practical implementation of GDP; When is a wholesale license necessary?
• GDP Non-compliance reports – GDP deviations and observations 2025; Potential preventive measures
• Vehicle qualification – Best practice from ECA training
• Storage at -40 °C – GDP for biopharmaceutical API
• Excursus – AI applications in the GDP environment

During the final Q&A session, numerous interesting aspects were raised and discussed. Following the webinar, the speaker, Dr Christian Grote-Westrick, provided written answers to all submitted questions.

Below you will find Part 4 of the questions and answers. All responses reflect the speaker’s personal views based on his professional experience. Part 1 (returns/Swissmedic, USA, HPRA), Part 2 (temperature control) and Part 3 (transport validation and Annex 15) can be found in our news archive. The fifth and final part will be published next month.

Veterinary Medicinal Products

1. In some countries, not all distributors of veterinary medicinal products have WDAs yet, let alone GDP certificates, mainly due to regulatory backlogs. What are the expectations in this regard?
Answer: As soon as wholesaling is performed by companies handling veterinary pharmaceuticals a WDA is obligatory. If this company represents a logistics service provider (product still belongs to you) a "commercial" GDP certificate (not issued by competent authority but by commercial organization) of the company may be available. This could be a parameter in your supplier qualification, but this is not an official GDP certificate (also not required, because no wholesaling is performed).

Computer System Validation (CSV) / Artificial Intelligence (AI)

1. How should validation of Microsoft SharePoint for the storage of GDP documentation be approached?
Answer: Short answer: if MS SharePoint is validated according to ALCOA++, it is suitable for document control. SharePoint offers versioning of documents and comments by authorized users with time stamps, which can be applied for document authorship / review / release evidences. A validation approach which covers ALCOA++, especially availability, durability and  protection for electronic data would be recommended.

2. Regarding validated prompts, how was the validation process conducted?
Answer: So far, an approach: training of the AI until the process is clear in its execution can be seen as design qualification, because their own requirements (user requirement specification) is matched with AI abilities. Often no influence can be made on installation and operation, thus, especially properties such as reproducibility, repeatability and correctness should be the target in PQ. Here, a static AI represents a prerequisite.

3. Have you received any feedback during regulatory inspections regarding documents created using AI (e.g. Management Review, Periodic Review), and what are regulators’ expectations?
Answer: As soon as AI activities are subject of human review and release and prompts contain an individual validation, those supportive tasks have been seen as beneficial for first-time-right documentation.