Report of the GMP/GDP Inspectors Working Group published

Recommendation

7/8 May 2024

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The EMA's GMP/GDP Inspectors Working Group has published its annual report (compiled already in August this year).

This group of GMP Inspectors meets on a regular basis four times a year. The group consists of representatives from the GMP inspectorates of the European Economic Area Member States, a representative from the European Commission (DG Enterprise and Industry) and observers from EDQM, the inspectorates of the countries in relation with the EU and MRA partner countries. The EMA provides the chair and secretarial support for these meetings.

The participants of these meetings discuss new and revised GMP-related guidances, normally developed by drafting groups, work related to Mutual Recognition Agreements, how new legislation impacts GMP inspection activities and harmonisation of GMP inspections. The outcome of the work is summarised in annual reports. The reports also briefly summarise number and outcome of GMP inspections in third countries and the status of the current Mutual Recognition Agreements (MRAs) and other agreements on GMP.

For further details please see the "Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2016".