Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 1

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 1 of the Questions and Answers

Below you will find the first part of the questions and answers. All answers reflect the speaker's opinion based on his experience. Parts 2 and 3 will be published over the next two months.

1. Regarding GDP-QMR: Have any regulations changed recently, or will any changes occur soon?
Answer: Latest version of EU GDP is Nov 2013 and currently no updates are known. Presented updates in corresponding webinar considers national guidelines and recommendations to interpret and realize European requirements.

2. Contracted distributors in the EU and third countries - Vendor evaluation, including GDP authorizations/certificates and QTAs, are available. The contract partner (acceptor) is the product owner after receipt. What are the current expectations regarding audits (on-site, remote, other alternatives)?
Answer: Since contract partner becomes owner of pharmaceutical product after receipt, following activities are designated as pharmaceutical wholesaling. The required Wholesale Distribution Authorisation (WDA) is available (as described), therefore an audit is not required. If the partner would take over wholesaling (procurement, storage, distribution) activities on your behalf, an audit would be a substantial part of supplier qualification and monitoring.

3. Do we need a specific license/certificate to distribute medicines to a patient's home?
Answer: Delivery of medicinal products to patients only via pharmacies with dispending authorization (according to chapter 5.3 EU GDP).
A special scenario: you deliver pharmaceuticals to a patient´s home being the contracted distribution partner of a pharmacy, i.e. product does not belong to you and you act as a transport service provider.

4. When we talk about a room temperature range of 20-25°C in the US, what transport conditions are expected in the US?
Answer: As highlighted in USP <1079> designation of temperature by manufacturer applies for storage and transport. If 20-25 °C is defined and designated it also applies for transport.

5. Per dossier definition: "Do not store above 25 °C" - What are the current expectations regarding the transport temperature range? 15-25 °C or 2-25 °C?
Answer: Since there are no further requirements by its manufacturer it is difficult to define "standard" lower temperature limits. Here product properties must be considered. If this is not defined by manufacturer also none applies for transport. Maybe consultation of the manufacturer is recommendable in order to clarify. If this does not lead to conclusion an own risk-based approach resulting into a lower limit such as "do not freeze" would disarm the situation.

6. SwissGMDP ID for Switzerland - What is the equivalent database for Germany?
Answer: EudraGMDP (EudraGMDP - Public Layout)

7. PIC/S states different modes of inspecting companies by authority inspectors. However, does this also mean that private companies will be allowed to conduct remote audits as an alternative to on-site audits? As far as I know, EU-GMP/GDP guidelines still require companies to conduct on-site audits.
Answer: Remote audits are generally possible as an alternative to on-site audits. As usual, it is a risk-based decision since an on-site audit would definitely reveal more issues than a remote one. The latter would probably make it more difficult to identify findings since you are controlled by the auditee (because of being guided through a warehouse via tablet). I would recommend to perform initial audits on-site and in case of good compliance a remote one as the next one.