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Inspections - Activities of the sector

Overview

The EMEA's Inspections Sector deals with a number of tasks laid down in Regulation (EC) 726/2004, specifically those concerned with the coordination of the verification of compliance with the principles of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and with certain other aspects of the supervision of authorised medicinal products in use in the European Community. The Sector's activities are summarised in Chapter 4 of the EMEA's work programme and annual reports.

The Sector is responsible for co-ordinating any inspection requested by the CHMP or CVMP in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to these committees in accordance with Community legislation. These inspections may cover GCP, GLP, GMP, Pharmacovigilance (PhV) or they may be performed in the context of Vaccine Antigen Master File (VAMF) and 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 and/or to ensure compliance with GMP, GCP, GLP or Pharmacovigilance quality assurance systems.

The Sector organises and chairs regular meetings of European Economic Area (EEA) GCP and GMP inspectors where harmonisation of inspection related procedures and guidance documents are developed. This includes the development of the new EudraGMP database.

The secretarial support to the joint CHMP/CVMP Quality Working Party is provided by the Sector. In addition an EMEA Process Analytical Technology team, a forum for dialogue and understanding between the Quality Working Party and the GMP/GDP Inspectors Working Group with the aim to review the implications of PAT has been set up under its responsibility.

As part of the Agency’s responsibility for the coordination of the supervision of authorised medicinal products under practical conditions of use, the Inspections Sector, in cooperation with the EDQM, operates a Sampling and Testing Programme.

Communication and action by Member States in response to suspected Quality Defects relating to centrally authorised medicines are also coordinated by the Sector.

Apart from inspection and supervision related activities, the Agency has been given responsibility for issuing Certificates of Medicinal Products in accordance with WHO requirements which confirm the status of centrally authorised medicinal products and GMP compliance of the sites manufacturing the pharmaceutical forms.

The Sector also coordinates activities in connection with the GMP annexes of the various Mutual Recognition Agreements (MRA) that have been negotiated between the European Community and non European countries. International Cooperation includes work with the U.S. Food and Drug Administration (FDA) and the International Conference on Harmonisation (ICH / VICH).

Whilst most scientific activities of the Agency are divided between medicinal products for human and for veterinary use, the tasks of the Inspections Sector are typically common to both types of products. The Inspections Sector forms part of the Veterinary Medicines and Inspections Unit within the Agency.