Questions and Answers from the ECA Webinar "GDP Update 2024" - Part 2

Almost 100 participants attended the ECA Webinar "GDP Update 2024" on 12 March 2024. The aim of the two-hours 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 2 of the Questions and Answers

Below you will find the second part of the questions and answers. All answers reflect the opinion of the speaker based on his experience. Part 1 (questions 1 to 7) can be found in our news archive.

8. What kind of activities can be delegated to non RP/QA?
Answer: In general all activities described in chapter 2.2 GDP, but delegation should be documented (person in charge, qualification/training content).

9. If a temperature excursion is notified by a customer who is the MAH of the product and the transport is performed ex works (EXW) by them, do we need to open a deviation, as product manufacturer?
Answer: In terms of EXW customers pick up product at ramp and takes over responsibility for deviations during his transport. Please note: the customer must be authorized to receive pharmaceuticals.

10. Can you please provide examples of passive protective solutions for cold temperature excursions (just like thermal blanket from hot temperature excursions)
Answer: Next to thermal blankets, Styrofoam boxes or isolated containers/semi-trailers (passive protection). Here, often transport providers have service categories ensuring catching temperature peaks by applying these boxes or preconditioning products in warehouses before loading to a plane on an airfield.

11. Can we use the same warehouse for WDA and MIA by using electronic quarantine for non released products?
Answer: Yes, and electronic system should be subject of validation to demonstrate that mix-up is not possible (by PQ provocation tests). The status of the products must be recognizable and with integrity (identification, traceability) at any time.

12. For pure commercial transactions distributions (HUB) - is it required/recommended to audit these suppliers? Physical flow is from supplier to costumer, but there is a broker in the middle related to funds flow.
Answer: If the supply chain includes HUBs (managed by an external company) and downstream transport companies, then all HUBs and their QMS should be subject of an audit to ensure their ability to perform changes or deviations. Usually the period of stay is less than 48 h, which allows not to speak of storage here and no WDA is required.
In this scenario I understand that the supplier is either manufacturer (German law: § 13 AMG) or wholesaler (§ 52a AMG) of pharmaceuticals and is not target of an audit since he is regularly controlled for up-to-date GDP/WDA/Manufacturing License and in turn is regularly inspected by competent authorities.

13. Is it required to have a lower temperature limit for the warehouse, and if yes, can it be below 15 °C?
Answer: Temperature limits arise from product specifications. If the worst case product allows storage below 15 °C, then yes. Same for the upper specification limit. If it is only one or two products which limit storage below 15 °C since their lower limit is 15 °C, then maybe warehouse split is recommendable in order to reduce the temperature maintenance for a warehouse part. (Important: temperature mapping after splitting).

14. If a frozen product has been shipped out without the provided data logger inside the insulated box, would it be still possible to give the approval to use such a product if we have a documented evidence that the duration of the shipment has not exceeded the time period for which the insulated boxes are validated?
Answer: If this transport is covered by validation, then acceptable. But the validation must cover it by duration and worst case (outside) temperature. The described incident must be documented within a deviation that can be closed based on validation process.