GMP/GDP Inspectors Working Group
Table of contents
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 (GMDP IWG).
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.
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Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2017 (PDF/393.63 KB)
First published: 06/08/2018
Last updated: 06/08/2018
Guidance for Rapporteurs of documents developed by the GMP/GDP Inspectors Working Group (PDF/107.13 KB)
First published: 01/04/2010
Last updated: 01/04/2010
Mandate, objectives and rules of procedure for the GMP/GDP Inspectors Working Group (GMDP IWG) (PDF/105.17 KB)Adopted
First published: 13/08/2007
Last updated: 27/02/2014
Work plan for the Good Manufacturing Practice / Good Distribution Practice Inspectors Working Group 2018 (PDF/119.87 KB)Adopted
First published: 14/02/2018
Last updated: 14/02/2018
Questions and answers on GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances (PDF/118.76 KB)
First published: 05/02/2021
Guidance related to GMP/GDP and PMF distant assessments (PDF/251.77 KB)
First published: 23/11/2020
Reflection paper on good manufacturing practice and marketing authorisation holders (PDF/469.04 KB)Draft: consultation closed
First published: 20/01/2020
Last updated: 29/04/2020
Consultation dates: 17/01/2020 to 17/07/2020
Concept paper on good manufacturing practice and marketing authorisation holders (PDF/121.01 KB)Draft: consultation closed
First published: 04/10/2016
Last updated: 20/10/2016
Consultation dates: 01/10/2016 to 31/12/2016
Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice (PDF/116.83 KB)Draft: consultation closed
First published: 23/05/2018
Last updated: 23/05/2018
Consultation dates: 23/05/2018 to 31/08/2018
Concept paper on new guidance for importers of medicinal products (PDF/80.45 KB)Draft: consultation closed
First published: 29/05/2015
Last updated: 29/05/2015
Consultation dates: 29/05/2015 to 29/08/2015
Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products (PDF/97.13 KB)Draft: consultation closed
First published: 05/02/2015
Last updated: 05/02/2015
Consultation dates: 05/02/2015 to 31/03/2015
Draft concept paper on revision of annex 17 of the good-manufacturing-practice guide (PDF/83.73 KB)Draft: consultation closed
First published: 27/11/2012
Last updated: 27/11/2012
Consultation dates: 27/11/2012 to 28/02/2013