Inspections

The European Medicines Agency is responsible for co-ordinating inspections to verify compliance with the principles of:

• Good manufacturing practice (GMP);
• Good clinical practice (GCP);
• Good laboratory practice (GLP)

Inspections also verify compliance with other aspects of the supervision of authorised medicinal products in use in the European Union. These are described in Regulation (EC) 726/2004.

Inspection requests from committees

The Agency is responsible for co-ordinating any inspection requested by the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP) in connection with the assessment of marketing-authorisation applications or matters referred to these committees.

These inspections may cover GCP, GLP, GMP, pharmacovigilance (PhV) or vaccine antigen master file (VAMF) or plasma master file (PMF) certification. They may be necessary to verify specific aspects of the clinical or laboratory testing or manufacture and control of the product or to ensure compliance with GMP, GCP, GLP or pharmacovigilance quality assurance systems.

Inspector meetings

The Agency organises and chairs regular meetings of GCP and GMP inspectors from the European Economic Area (EEA). These meetings:

• develop harmonisation of inspection-related procedures and guidance documents;
• manage the Agency's process analytical technology (PAT) team. This is a forum for dialogue and understanding between the Quality Working Party and the GMP/GDP Inspectors Working Group with the aim of reviewing the implications of PAT has been set up under its responsibility.

Sampling and testing

The Agency implements a sampling and testing programme aimed at supervising the quality of centrally authorised medicines available on the European market.