Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 1

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 an 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.

Read part 1 here. Part 2 and part 3 will be published in a few weeks.

Questions and Answers (Part 1)

1. As a wholesaler we have a simple complaints procedure. In this procedure we describe that all the incoming complaints are directly transferred to the supplier of the Pharmaceuticals we distribute. Logistic complaints are handled by us. Is that enough in your opinion?
Answer: Since your complaint management includes an initial risk categorization (logistic complaint e.g. transport damage and quality related complaint e.g. contamination of the product, non-sterility), in my opinion this procedure is sufficient. I would ensure that this risk-based approach is mentioned in your SOP.

2. Veterinary product with the following storage condition on the label "The product does not require any special conditions". How should it be stored/transported?
Answer: EMA feedback was here very clear, if manufacturer does not label temperature conditions, it must be based on stability studies at climate zone I and II (ICHQ1). These stability studies are essential studies in order to durability of (veterinarian) medicinal products. Thus, the product shall be stored at maximum 25 +/- 2 °C. Same would be expected for transport, since transport is simply spoken an extended warehousing process.

3. Some authorities do not upload GMP/GDP certificates and non-compliance report to EudraGMDP, like Italy. Where can I find those?
Answer: The EUDRA GMDP database represents unique possibility to access these reports. As a non-authorial human being I am afraid we do not have access.

4. The distribution goes via hubs that are transit locations. The Pharmaceuticals are not stored there. The whole transport to the stores is < 8 hours. These locations are therefore a part of the GDP License of the Central Storage. What is your opinion on that?
Answer: Wholesaling is represented by 3 processes: procurement, storage and distribution. As soon as one of these processes applies in your locations you are a wholesaler with the duty of application of wholesaling authorization (§52a AMG). Here it is important to define: what is storage? or: after how many hours does storage begin? Here we recognize that authorities such as MHRA, HPRA accept 36 / 48 hours in order to allow realization of weekend scenarios. Same experiences were made with German authorities. Important to define in your documentation (risk analysis): when does rearrangement end and when does storage start? Hubs must be managed according to GDP (temperature monitoring, access control, pest control), if externally managed your audit is documenting that. In this case (when storage does not apply) no individual wholesaling authorization for this hub is necessary.

5. Perhaps it would be possible to give an example, to a scenario, where there is no logger for temperature in the storage areas needed?
Answer: If a warehouse is mapped in summer and winter and both at coldest and hottest spot no excursion of temperature could be detected, then routine storage without temperature loggers are possible since you validated it. Validation makes verification unnecessary. In case of changes (e.g. building extension) re-mapping could be necessary. Furthermore, the products stored in this area should have an accepted temperature range related to that (e.g. 5-25°C).

6. Chapter 9 transport: route validation, expectations? Transporter with hundreds of routes all over Europe.
Answer: A worst case scenario should be defined: a risk assessment involving potential longest route, climate at destination and place of origin and worst case product can help to define individual worst case route which is representative for all transports.

7. GDP documents (forms which are manually filled in) scanned and then digitally archived for 15 years - can we throw away raw data in this case?
Answer: In case of electronic archiving, we must ensure that digital version of record is equal to paper-based record. Here a review step is highly recommendable to check whether scan is readable and complete. A test for data integrity (can I manipulate, delete and quickly recover electronic records from archive?) is also further assuring that. In this case paper-based documentation may be discarded.