16/17 October 2019
EMA's GMP/GDP Inspectors Working Group has published its annual report. This group of senior GMP Inspectors meets on a regular basis four times a year. The group consists of representatives of 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 accessing to the EU and MRA partner countries. The Sector provides the chair and secretarial support for these meetings.
The meetings consider new and revised GMP related guidance, normally developed by drafting groups, work related to Mutual Recognition Agreements, how new legislation impacts GMP inspection activity 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.
Please see the Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 for more detailed information.