Annual Report and updated Work Plan of the GMDP Inspectors Working Group - What's going on in GDP?

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

On 28 April 2023, the European Medicines Agency (EMA) published two new documents on its website: 

• Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2022 (Document EMA/INS/GMP/837536/2022)
• Work plan for the Good Manufacturing Practice / Good Distribution Practice Inspectors Working Group 2021-2023 (Document EMA/14021/2023)

The GMP/GDP Inspectors Working Group (GMP/GDP IWG) was established at EMA in 1996. The group meets four times a year and consists of representatives of the GMP inspectorates of the European Economic Area Member States, a representative from the European Commission and observers from EDQM, the inspectorates of the countries accessing to the EU and MRA partner countries.

Annual Report 2022

From the annual report, the following aspects related to GDP are worth mentioning:

• Section "3. GMP and GDP inspections in 2022" states that "the current COVID-19 public health emergency continues to have a considerable impact on the work of GMP and GDP inspectors. Although on-site inspections have resumed where possible, travel restrictions and hygiene measures continue to impact on-site inspection as the primary means of verifying compliance with requirements." In this context, the extension of the GDP certificates until the end of 2023 is pointed out.
• In Section "6. GMP and GDP guidance" reference is made to the new Q&A documents, especially those dealing with the requirements and changes related to the veterinary medicinal products law adaptation (Q&A on the requirements for active substances used as starting materials in veterinary medicinal products).
• Section "8. EudraGMDP database" mentions the integration of EudraGMDP with EMA’s Organisation Management Service (OMS) and the extension of the Wholesale Distribution Authorisation (WDA) and Active Pharmaceutical Ingredients Registration (API-Reg) to the veterinary domain.