Questions and Answers from the ECA Webinar "GDP Update 2024" - Part 1

Almost 100 participants attended the ECA Webinar "GDP Update 2024" on 12 March 2024. The aim of the two-hour event was to give an overview of current requirements and latest developments in GDP.

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

• ZLG Document: Inspection of Transport Process Suitability
• GDP Association: GDP Checklist
• EMA/MHRA: Extension of GDP Certificates
• ICH: New Version of ICH Q9
• Swissmedic: Database & Regulated Quarantine Shipment
• GDP in the US: Drug Supply Chain Security Act (DSCSA) & USP Chapter <1079.2>
• GDP Non-Compliance Reports: GDP Failures & Ideas to prevent it
• FDA: Recalls due to Pest Control Problems
• Counterfeit Medicines: Falsified Semaglutide Products

In the Q&A session after the presentation, many interesting aspects were discussed. The speaker, Dr Christian Grote-Westrick, has answered the questions in writing afterwards.

Part 1 of the Questions and Answers

Below you will find the first part of the questions and answers. All answers reflect the opinion of the speaker based on his experience. Part 2 will be published next month.

1. Now that the MDR and IVDR have been fully implemented, is it expected that there will be a revision to the current EU GDP Guidelines from their current 2013 version to incorporate GDP for medical devices as well as general updates needed after 10 years of publication?
Answer: Currently there are no planned updates for EU-GDP. Since implementation of MDR the term “transport” now appears 8-times in this medical device guideline (for manufacturer, distributor, supplier) indicating that good storage & transportation practice moves into this product regulation as well. Notified Bodies (depending on auditor´s experience / expertise) emphasize this topic remarkably in current audits. For medical device business only “full GDP compliance” is not expected / mandatory.

2. Are there any plans for authorities to issue specific guidelines regarding the distribution/transportation of ATMPs (cell and gene therapies)?
Answer: Until now there is no specific GDP guideline for ATMPs as it exists for APIs or veterinary drugs, but for ATMPs and its wholesaling same GDP requirements as for “general” pharmaceuticals apply.

3. A recent update to the Irish Health Authority (HPRA) GDP Guidelines included provisions on the use of outsourced RPs. Should the industry be concerned with over-reliance on contract-based Responsible Persons who may not always be continuously contactable as required in the EU GDP Guidelines?
Answer: Especially for small enterprises contract RPs represent a quick solution for realization of GDP requirements. Here, contractual agreement between company and external RP should define required availability.

4. How do you define "critical" equipment?
Answer: In GDP environment critical refers to potential product impairment regarding quality and safety, e.g. temperature loggers, A/C, refrigerators, freezers and corresponding rooms. Here your risk management will define criticality.

5. Is the EudraGMDP database always up-to-date? I have the impression that the database is not up-to-date. Some countries do not upload WDA or GDP certificates, e.g. Poland and Italy.­
Answer: Until now, no negative experiences have been made with this database regarding actuality. The problem of non-uploading (or maybe absence) of NC-reports by individual countries is known.

6. The guidance of Swissmedic on Quarantine shipment is quite detailed, but is it aligned or different from guidance of EMA or FDA?
Answer: Explicit guidelines for quarantine shipment are currently not available, but it is possible under consideration of EU GMP 3.21; 5.13; 5.32iii; or 21CFR211.80d; 211.82 b and 211.89.

7. For the USP 1079.2 'storage range' - in the past the '20°C-25°C' range was considered/accepted as equivalent to '15°C-25°C' as now in EU. Will that still be the case in future since the limits or allowed excursions seems much stricter.
Answer: Until now, no tendencies are known to modify setting regarding ambient temperature conditions in USP <1079>.