Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 3

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 two months ago and Part 2 (Questions 8 to 14) last month. Read here the final Part 3.

Questions and Answers (Part 3)

15. In a cold storage warehouse: Is the monitoring of the worst case (hot spot) enough?
Answer: Yes, because here you will have the first potential temperature excursion and you will recognize it.

16. Considering EU GDPs require storage/transport per labeling storage conditions and there is more leeway in the US (can justify not monitoring via risk assessment with data) - would any transport/storage occurring in the US (and elsewhere) for drug products that will eventually be sold in the EU need to comply with EU GDPs?
Answer: Due to the mutual recognition agreement between the US FDA and Germany (ZLG) from June 2019 I would answer this question with no. There is a US compliance area and an EU compliance area and based on this MRA both parties accept compliance requirements of each other.
But what will happen if FDA inspects a European company for instance due to a for-cause audit? Will it then be 21CFR211 and USP requirements or EU GDP? This question is difficult to answer.

17. In the room temperature storage warehouse, is it enough to monitor the worst case (hot spot)?
Answer: The coldest spot is also required since room temperature has a lower limit as well (for example 5°C / protect from freezing).

18. To your earlier point about "validating" storage/transport conditions under worst case scenarios and not routinely monitoring shipments with loggers - will EU regulators accept this?
Answer: If you demonstrate a worst-case transport with specific equipment (e.g. reefer container ship transport) at hottest and coldest exposed temperatures without deviations in temperature range (product related), then you exhibited a suitable transport equipment.
In general, if you cannot validate a process, you need to verify it via controls. If you validate the process, the verification process is not required as well.

19. We have a medicine (an important antidote) but our supplier nor the MAH can provide us a CoA, BRA, or CoC. (How) is this possible, is there a base to force the liberation of these documents?
Answer: According to Annex 16 EU GMP the QP has to issue the certification. Maybe a contractual agreement is necessary here or contact to competent authority.

20. Are you per GDP required to audit the supplier of your medicinal products? Both in the situation when you buy from the manufacturer directly or when you buy from another party (WDA-license holder)?
Answer: An audit is not required, but a described and documented qualification process which includes check for WDA (§52a AMG) or manufacturing authorization (§13 AMG). This must be refreshed on a regular basis.

21. Can we only deliver to MIA holder? Not the manufacturer, only WDA holder (Chapter 5.3 GDP - Qualification of customers)
Answer: Either recipients have a WDA or pharmacy registration number. Your system should allow to maintain this qualification record for individual recipients and must be reviewed on regular (annual) basis.