GMP/GDP Inspectors Working Group

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The Sector draws on the expertise of member states’ inspectorates for the fulfillment of many of its GMP related tasks. This is primarily achieved through the GMP/GDP Inspectors Working Group.

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. It is also where community-wide procedures relating to GMP inspections, known as the Compilation of Procedures are developed. The group interacts with other bodies e.g. PIC/S and EDQM. GMP related issues concerning centrally authorised products and GMP inspections co-ordinated by the European Medicines Agency in connection with these, are also considered at the meetings. The Group’s work plan is published annually.

The functions of inspection and assessment have always been complementary activities and there is increasing awareness of the importance of interactions between GMP inspectors and assessors. The European Medicines Agency therefore arranges a joint meeting between this group and Quality Working Party at least once a year. The group contributes to the Agency PAT team, which is made up of representatives of Quality Working Party, Biologics Working Party as well as the GMP/GDP Working group.

GMP inspectors maintain a dialogue with GCP Inspectors on areas of common interest in particular the interface between GMP for investigational medicinal products and GCP. A GCP / GMP subgroup assists in the interpretation of GMP in a number of specified areas.

The group aims to meet with its interested parties, representatives of European industry associations and relevant professional associations, at least once a year.

Send all queries regarding this content to: Send a question to the European Medicines Agency.

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Concept papers and reflection papers

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Document(s) Language Status First published Last updated Effective Date
Concept paper on good manufacturing practice and marketing authorisation holders (English only) draft: consultation closed 2016-10-04 2016-10-20  
Concept paper on new guidance for importers of medicinal products (English only) draft: consultation closed 2015-05-29    
Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products (English only) draft: consultation closed 2015-02-05    
Draft concept paper on revision of annex 17 of the good-manufacturing-practice guide (English only) draft: consultation closed 2012-11-27