This content applies to human and veterinary medicines.
The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived.
Questions and answers concerning the interpretation of the two GLP Directives can be found in Questions and answers concerning the implementation of Directives 2004/9/EC and 2004/10/EC on Good Laboratory Practice. The questions were discussed by Commission services and representatives from the Member States' GLP-monitoring authorities and the answers were approved by the EU GLP Working Group. The document attempts to provide guidance to monitoring authorities, regulatory authorities and test facilities. The answers represent the opinion of the EU GLP Working Group.
The Procedure for co-ordination of GLP inspections describes the co-ordination of GLP inspections of the non-clinical safety, toxicological and pharmacological studies proposed in human and veterinary applications for marketing authorisations and various post-authorisation applications submitted to the European Medicines Agency through the centralised procedure. It is effective as of 27 September 2012.
The European Medicines Agency has a co-ordinating role for these inspections, whilst the responsibility for carrying them out rests with the Competent Authority under whose responsibility the test facility falls.
Ad hoc GLP Inspectors Working Group
The ad hoc GLP Inspectors Working Group focuses on harmonisation and coordination of GLP-related activities at Community level. EMA's Clinical and Non-clinical Compliance Service chairs and provides secretarial support to the ad hoc GLP Inspectors Working Group. Members provide the expertise to carry out the group's tasks and play a key role in the development of collaborative projects. They support the coordination of the provision of GLP advice and provide a link with other groups such as the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP). These links include support to the non-clinical assessors in verifying GLP compliance and contributing to the drafting/revision of guidance addressing GLP compliance.
The ad hoc GLP Inspectors Working Group meets once every two years at EMA with representatives of the good clinical practice (GCP) inspectorates of the European Economic Area.
Documents of interest
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