Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 2

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 2 of the Questions and Answers

Below you will find the second part of the questions and answers. All answers reflect the speaker's opinion based on his experience. Part 1 (questions 1 to 7) can be found in our new archiv. Part 3 will be published next month.

8. What are the requirements for an RP in Germany? 2-hour residency, 10% on-site presence?
Answer: EU GDP chapter 2: The responsible person should meet the qualifications and all conditions provided for by the legislation of the Member State concerned. A degree in pharmacy is desirable. The responsible person should have appropriate competence and experience as well as knowledge of and training in GDP.
There is no restriction regarding presence or residency in Germany. A mixture of internal/external training and documented experience as qualification status is recommendable.

9. Transport Validation: We are a startup company and currently have no products in our warehouse. We have outsourced transport services. Are we responsible for transport validation?
Answer: If not further stated in contractual agreement, startup company remains responsible.

10. Mapping Study: Does it need to be executed every year in the summer or winter season?
Answer: After successful mapping no further mapping is required unless there are changes. In terms of changes a controlled process (change control) must be done including a risk assessment deciding about activities (e.g. re-mapping).

11. We have a warehouse in Stuttgart and were granted a Wholesale License in May 2024. What is the re-inspection interval for GDP inspections by the Regional Council Inspector?
Answer: Usually between 2-5 years.

12. Can an RP in Germany perform a fully remote assessment of a supplier located in India?
Answer: In general, yes, but an initial audit especially in countries without regular access would be strongly recommended.

13. If the company has no internal auditors, can the RP perform self-inspections?
Answer: Yes, but consider internal qualification requirements for internal auditors (e.g. training on ISO 19011) is also necessary for the RP.

14. The QMR of the company is located outside the EU. Can the QMR also execute remote self-inspections in place of the RP?
Answer: Yes, according to chapter 2.2 EU GDP RP is responsible for setup and maintenance of QMS, but like all other tasks this can be delegated and the QMR can perform internal audits. This delegation should be available in written and the RP remains responsible.