Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 2

More than 60 participants attended the ECA Webinar "GDP Update 2023" on 16 March 2023. The aim of the two-hour event was to give a overview of current requirements and latest developments in GDP - those already realized and those planned.

The following topics, among others, were addressed:

  • GDP Non-Compliance Reports EU (Findings & possible Prevention)
  • New publications by EMA
  • FDA Warning Letters GDP 2022 (Findings & possible Prevention)
  • New publications by FDA
  • Transport validation: GDP + ASTM

In the Q&A session after the presentation, many interesting aspects were discussed. A total of around 20 questions were addressed to the speaker, Dr Christian Grote-Westrick, which he answered in writing afterwards.

We have compiled a selection of the questions and answers for you. All answers reflect the opinion of the speaker based on his experience.

Part 1 (Questions 1 to 7) was published last month and Part 3 will be published in a few weeks. Read here Part 2.

Questions and Answers (Part 2)

8. WDA holders can only deliver goods to other WDA holders and to persons who can deliver goods to the public. What about delivery with, for example, online pharmacies to the home of patients? What kind of license do they have?
Answer: Chapter 5.3 GDP - Qualification of customers
Either recipients have a WDA or a pharmacy registration number. Your system should allow to maintain this qualification record for individual recipients and must be reviewed on a regular (annual) basis.

9. Shipment under quarantine out of our warehouse requested by our customer - what do we need to check? What are we responsible for? FMD: parties must set up a system to verify: do we need to link ourselves to NMVS or is it also okay if we send a CSV file with serialization numbers to the customer (MAH) and they do the check?
Answer: Shipment under quarantine is possible if you demonstrate in writing that it remains under control: e.g. the product is under quarantine because the sterile test is still running ' ensure that in terms of a positive sterile test you are able to block and retrieve this product without danger of unwanted delivery. FMD: if you are a wholesaler for products that fall under FMD an own access to the system is required (registration and information delivery).

10. Is there a restriction to in what way you should do a risk assessment with changes? Normally the changes are not that big to do an FMEA assessment. We discuss it in the CAPA or change. Is that enough in your opinion?
Answer: All changes contain a potential risk to the established system. Therefore, a risk assessment is required for all changes. If the risk is very low, then maybe no further action is required, but it requires a documentation to prove it.

11. Normally the health authority doesn't like the MKT to be used for assessment; can you comment?
Answer: MKT has been in discussion for a long time. To my point of view, it depends on the product and its temperature sensitivity. If your risk analysis points out that temperature does not play a crucial role for the product and warehousing represents a safe process (controlled, isolated building, mapping) than MKT may be applied.

12. We transport all our pharmaceuticals in isolated trucks (transport time 8 hours or less). Is a validation in the winter and summer enough to not monitor transport conditions? With a delay in transport, the truck driver will turn on the conditioning system. Can that get accepted (and how) to NOT do conditioned transportation?
Answer: In general, winter and summer transport validations are sufficient since they represent worst case scenarios. Furthermore, a proactive activation of air-conditions in trucks are also imaginable, as soon as this process has been considered in your risk analysis and is defined as a potential risk-mitigating step.

13. Are the tests for transport validation the responsibility of the transporter? Is this not more the responsibility of the product owner?
Answer: The wholesaler is responsible for the validation of further transports, since he uses own (or third party) transport equipment. The product owner (MAH) cannot know these pathways in downstream transport for the product, which is managed by wholesalers.

14. Can you clarify use of MKT - it is acceptable in the US, however, I thought it was not allowed in the EU?
Answer: see question 11.

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