Implementing GMP/GDP in the EU - the work of the GMP/GDP inspectors working group

Although European Community Guidelines and associated documents on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) for medicinal products (both human and veterinary) are formally published by the European Commission, the responsibility for their day to day application rests with the European Medicines Agency (EMEA).

The EMEA has recently published the mandate, objectives and rules of procedure for the GMP/GDP inspectors working group (GMDP IWG), which advises on the execution of these responsibilities by the Agency.

The paper traces the history of the development of the Group to its current status and explains the role and responsibilities of the Group and its interactions with the Agency, the Commission and other stakeholders (including industry) in this area.

Areas covered by the work of the Group include:

• development of GMP/GDP related guidelines for adoption by the Commission
• development of high-level procedures for the conduct of inspections
• advice on practical application of guidelines and their interpretation
• development, implementation and monitoring of Mutual Recognition Agreements (MRAs) between the EU and non-EU states, and
• co-operation with other bodies and stakeholders

The paper also explains the composition and rules of participation of the Group and its rules of procedure and the responsibilities of the EMEA secretariat to provide administrative support for its work.

For all who have an interest in how the rules and requirements of GMP in the EU are developed the document - EMEA/INS/GMP/470302/2006 available at www.emea.europa.eu/Inspections/docs/47030206en.pdf - provides an informative, valuable and welcome insight into that process.