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At the Heads of Medicines Agencies meeting in Lisbon in July 2007 it was
decided that the names of the Ad Hoc GMP/GDP and the GCP Inspection Services
Groups should be harmonised and it was agreed that these groups should
therefore be called the GCP Inspectors Working Group and the GMP/GDP
Inspectors Working Group.
Mandate, objectives and rules of procedure for the new Inspectors Working
Groups were recently published and can be found in the following documents:
http://www.emea.europa.eu/Inspections/docs/23948607en.pdf
http://www.emea.europa.eu/Inspections/docs/47030206en.pdf
Co-operations with the European Commission, the EMEA and Heads of Medicines
Agencies are specified and composition and rules of participation are also
defined.
According to Directives 2001//20/EC respectively 2001/83(2)/EC conclusions
reached following a GCP or GMP inspection are recognised and valid
throughout the Community. The Inspectors Working Group provide input and
recommendations on all matters relating directly or indirectly to Good
Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good
Distribution Practice (GDP) irrespective of the marketing authorisation
procedure through different reporting lines as indicated in the documents.
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