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
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
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
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
This procedure describes the co-ordination of pre-authorisation GMP and
product/process related inspections of the manufacturing sites proposed in
human and veterinary applications for marketing authorisations under the