Good Manufacturing Practice (GMP) / Distribution Practice Practice (GDP) Inspectors Working Group
HumanCompliance and inspectionsRegulatory and procedural guidanceResearch and development
EMA draws on the expertise of member states' inspectorates for the fulfilment 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, WHO and the inspectorates of the countries accessing to the EU, and MRA and other trade co-operation partner countries. The Inspections Office provides the chair and secretariat support for these meetings.
The meetings consider new and revised GMP and GDP - related guidance, normally developed by drafting groups, work related to Mutual Recognition Agreements, how new legislation impacts GMP and GDP inspection activity and harmonisation of GMP and GDP inspections. It is also where community-wide procedures relating to GMP inspections, known as the Compilation of Union Procedures are developed. The group interacts with other bodies e.g. MRA Partners, PIC/S, WHO 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 liaises with the Agency Quality Innovation Group, which is made up of assessors and GMP inspectors, as well as the Innovation Task Force.
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.
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.