Europe: EMA Issues Revised Procedures on GMP/GDP Inspections & Exchange of Information

The text has been amended to introduce a quality risk management approach including minor editorial changes.

Formerly known as the “Compilation of Community Procedures on Administrative Collaboration and Harmonisation of Inspections”, the 295-page document is a tool for facilitating co-operation between the GMP and GDP inspectorates of the EU Member States and a means of achieving harmonisation. The procedures within it provide the basis for national procedures that form part of the national GMP inspectorates’ quality systems.

The Compilation has two parts: Part 1 covers procedures while Part 2 contains other documents such as the interpretation documents and forms used by regulators.

Revisions are issued following agreement agreed by the GMDP Inspectors’ Working Group, document review by the European Commission and then published on its behalf by the European Medicines Agency.

The compilation serves to establish and maintain a system for mutual recognition of national inspections in respect of the manufacture and, where relevant, wholesale distribution of medicinal products and for the administrative collaboration between Member States of the European Economic Area (EEA).

Document source: Compilation-union-procedures-inspections-exchange-information_en 2021.pdf