GMP News No. 519
22 February 2005
EMEA: Activities of Inspections Sector
1. Legal Basis
Council Regulation 2309/93 created the EMEA, setting out its core tasks. The Agency's Inspections Sector deals with a number of these tasks, 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 aspects of the supervision of authorised medicinal products in use in the European Community.
The Sector is responsible for co-ordinating any GMP, GCP or GLP inspections 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 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 or GLP and quality assurance systems.
Origin of GMP inspection in centralised procedures.
The Sector organises and chairs regular meetings of EU GCP and GMP inspectors where harmonisation of inspection-related procedures and guidance documents are developed.
In addition 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 and was responsible for the organisation of the activities within the GMP priority action area of the PERF programme. Last but not least, the Sector provides secretarial support to the joint CHMP/CVMP Quality Working Party.
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.
2. GMP Inspections in third countries
The GMP Inspection Services Group has reached agreement on a harmonised approach that will be applied by all the member states' inspectorates concerning the verification of GMP compliance at manufacturing sites located in third countries where no MRA applies. The details will appear in an amendment to the existing procedure for Co-ordinating the Verification of the GMP Status of Manufacturers in Third Countries, which forms part of the Compilation of Procedures and will be available on the EMEA web site in the next few weeks.
To avoid delays in the acceptance of any particular manufacturing site industry should, when planning to use a manufacturing site in a third country, provide accurate information on the inspection history of the proposed site, assure themselves that the site will be inspection-ready and initiate discussion with the responsible authority (i.e. the authority responsible for the importer) well in advance of the submission of a relevant application or variation.
3. GMP Inspection SOP
Procedure for co-ordination of GMP
inspections effective 15 August 2004