Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 3

Around 60 participants attended the ECA Webinar "GDP Update 2025" on 11 March 2025. The aim of the two-hour event was to provide an overview of current requirements and the latest developments in GDP.

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

• Parenteral Drug Association – Management of Last Mile
• Swissmedic – Control of counterfeit drugs / RP / Database / GDP Inspection
• FDA – Update on Mean Kinetic Temperature (USP Chapter <1079.2>) / Special focus: MKT in routine distribution
• PIC/S & EMA – Guidance on Remote Assessments & Remote RP
• IPEC – GDP for excipients
• MHRA – Guidance Wholesaler / Drug Procurement UK
• GDP Non-Compliance Reports – GDP violations & observations 2024 / Preventive Actions
• Transport Checklist – Chapter 9 EU GDP
• Self-Inspection Checklist – Chapter 8 EU GDP

Many interesting aspects were discussed during the Q&A session. After the event, the speaker, Dr Christian Grote-Westrick, answered the submitted questions in writing.

Part 3 of the Questions and Answers

Below you will find the third and final part of the questions and answers. All answers reflect the speaker's opinion based on his experience. Part 1 (questions 1 to 7) and Part 2 (questions 8 to 14) can be found in our new archive.

15. The RP has knowledge of EU GDP or EU GMP but no training certificates. The QMR has EU GDP or GMP training certificates. Can the QMR provide in-house training to the RP?
Answer: Normally the competent pharmaceutical authority would only accept a designation of a new RP if documented evidence for qualification is available. This should consist of internal and external trainings. If the QMR has certified experience then internal training can be performed by this person.

16. For the ongoing training of the RP, is an in-house training record sufficient to prove compliance to the inspector, or is outsourced training required?
Answer: Initial training see 15. / Ongoing training depends on several issues: (1) the expectations of responsible inspectorate, (2) qualification level of RP (becomes apparent in GDP inspection. Recommendation: same as for initial qualification – a good mixture of internal and external training.

17. Regulatory Update: Have there been any modifications to GDP regulations in 2024?
Answer: No, not to the EU GDP

18. According to EU GDP, is it allowed to be an RP for more than one WSL?
Answer: This is possible but should be still feasible for this RP (an individual employment agreement including working hours is recommendable)

19. Last Mile Transport: The characteristics of the product should be considered (e.g., temperature-sensitive products). What if these characteristics are unknown because the company is only a distributor and not the MAH? How should temperature excursions during last-mile transport be managed?
Answer: According to chapter 9 EU GDP: product should be transported in correspondence to label information or manufacturer´s information. If both are not available, there are no requirements which is according to product quality and patient safety quite unsatisfactory. Imaginably would be contacting MAH regarding this issue or an own generous risk assessment to at least specify broadly such as not more than 25°C and do not freeze.

20. Regarding remote RPs, it has been stated that handling returns cannot be done remotely. Does this also apply if storage is outsourced to a 3PL warehouse provider?
Answer: In principle RP can delegate return handling to a person with qualification at the 3PL. In that case, presence of RP is not required at all, but responsibility remains at RP. Performing return handling via remote inspection is risky since important parameters may be overlooked.

21. Can a Wholesale Distributor sell products via an online store?
Answer: Yes, but only over-the-counter and non-pharmacy online pharmaceuticals.

22. We use a temperature controller from an outsourced company, and the calibration is valid for one year. They replace the controller every year. Please guide us on how to execute a risk assessment and justify the calibration interval.
Answer: As the controllers are exchanged annually (and possess an individual current calibration certificate) the risk is rather small. To express this in a risk assessment, a FMEA approach is possible:

• Subject: temperature logger (name, model)
• Risk: invalid temperature recording during transport
• Probability of occurrence: 3 (evaluation range 1-5)
• Severity: 5 (evaluation range 1-5)
• Discoverability: 4 (evaluation range 1-5)
• Risk Priority Number I: 3x5x4 = 60 (if >25 not under control)
• Risk mitigating action: annual exchange of temperature loggers including calibration
• Probability of occurrence: 3 (evaluation range 1-5)
• Severity: 5 (evaluation range 1-5)
• Discoverability: 1 (evaluation range 1-5)
• Risk Priority Number II: 3x5x1 = 15 (if <25 under control)

23. Similar to RP qualification, should the QMR also have a qualification in pharmacy or a related field?
Answer: QMR qualification extends rather to guidelines the QMS is derived from (e.g. ISO 9001, 13485). A GxP training for the QMR is also quite recommendable.