Questions and Answers from the ECA Webinar "GDP Update 2026" - Part 3

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 3 of the questions and answers. All responses reflect the speaker’s personal views based on his professional experience. Part 1 (returns/Swissmedic, USA, HPRA) and Part 2 (temperature control) can be found in our news archive. Further parts will be published in the coming months.

Transport Validation

1. As a broker, what are my responsibilities in terms of transport validation? And what if I act not as a broker but as a wholesaler? In other words, who is responsible for transport validation?
Answer: If your responsibilities within the contractual agreement do not include the performance of transport validation, then the contracting company (deliverer) possesses this requirement.

2. Shipments of the API we receive from manufacturers in China are arranged by the supplier. Is it correct that they are responsible for shipping qualification and temperature mapping? And are we “only” responsible from the point at which we take over the goods (e.g. EU port)?
Answer: Yes, in this case the Chinese manufacturers organize shipment and must ensure correct handling of their APIs. Here the contractual agreement should define the handover point and switch of responsibility.

3. How should seasonal temperatures be considered when defining worst-case scenarios in transport validation, given their variability and the different latitudes and longitudes involved?
Answer: That is correct, therefore a validation period for defined worst-case route would be recommended.

4. What are the differences between transport qualification carried out by a pharmaceutical company that does not have its own means of transport and uses a transport company, and transport validation carried out by the transport company?
Answer: Finally, the pharmaceutical company remains responsible. Either transport validation can be provided by the transport company and represents essential part of supplier/service provider qualification or transport validation may be performed by pharmaceutical company together with the transport company.

Annex 15

1. Is Annex 15 also relevant when you only have a WDA?
Answer: No, Annex 15 does not apply directly to WDA owners, since it represents a requirement for pharmaceutical manufacturers (and API). Annex 15 describes a structured way of qualification (correct design, correct installation, correct operation) also considering a simulation of routine conditions (correct performance) so that GDP inspectors (who also do GMP inspections) often expect coverage of this structure.

2. Do validations under GDP need to fully comply with Annex 15, or is it sufficient to use it as guidance?
Answer: Yes, see answer 1.

3. Annex 15 is part of the GMP guideline. The process steps described are GMP-related. How does this relate specifically to GDP?
Answer: See answer 1.