Questions and Answers from the ECA Webinar "GDP Update 2026" - Part 2

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

Temperature Control

1. A product is labelled “Do not store above 25 °C” but does not include “do not refrigerate” or “do not freeze”. In this case, what would be an acceptable lower excursion limit during transport (e.g. if the temperature drops to 2 °C or 10 °C for a few hours)?
Answer: If there is no designation on product labels for lower temperature restriction, wholesalers may apply their own safety specification limits, but no one knows whether this makes sense, since only scientific stability data examination may deliver reliable results and limits. The RP could insist on recording temperature data to keep at least good records. If own lower temperature criteria are defined, then an individual acknowledgement of potential deviation could be requested from the Marketing Authorization Holder. But, in principle, if there is no defined lower temperature limit by the MAH, no restrictions to lower temperatures apply.

2. For products that are not thermally sensitive and for which stability data exist under accelerated conditions (e.g. 6 months at 40 °C or even 50 °C), what should be the target value for temperature loggers? There is considerable discussion about acceptable action limits.
Answer: It is important to note: the MAH could be the owner of stability data, allowing extra exposure to higher or lower temperature during transport. But these are not the mandatory stability data according to ICH Q1 for accelerated shelf-life determination, because here the medicinal product is, for example, stored for 6 months at 40 °C / 75% RH to prove a theoretical shelf life of 12 months at 25 °C / 65% RH. This does not mean that the medicinal product can now experience peaks up to 40 °C without the shelf life being affected. If one wants to demonstrate the stability of the medicinal product during potential peaks during transport, then the medicinal product would have to be exposed to these potential peaks and THEN an ICH Q1 stability study conducted to prove that despite the peaks, a shelf life of, for example, 12 months at those 25 °C / 65% RH is still maintained.

3. In controlled-temperature transport of medicines, if a validated route and a qualified carrier are used, is temperature monitoring with data loggers still mandatory?
Answer: If the transport process is validated (worst-case route under worst-case conditions) and transport equipment (carrier) is qualified, then no further verification by monitoring is required. If one cannot validate a process, it must be verified. If it is validated, 100% verification is not required. But please consider: were worst-case conditions really met in validation? It is often difficult to plan this in order to catch a day/period of deepest or highest outside temperatures. Thus, either a validation period makes sense or regular verifications (not 100%) of transport conditions support safety for distributed products.

4. If transport has been successfully validated, is it acceptable not to use data loggers during the transport of APIs or finished products?
Answer: See answer above.

5. If temperature records are incomplete for a short period due to system failure, how should the data be assessed? We usually review historical weather data and product stability data. Is this sufficient?
Answer: This would represent a possible way to deal with this deviation. In terms of repeated failures, a CAPA including preventive actions would be recommended.

6. The storage condition of a product is “store below 25 °C”, based on long-term stability studies at 25 °C / 60% RH. Is it acceptable to routinely transport the product at 2–8 °C for practical reasons?
Answer: Please see answer to question 1.