GOOD LABORATORY PRACTICE (GLP)

In the European Union and other parts of the world it is a regulatory requirement that studies undertaken to demonstrate the health or environmental safety of new chemicals or biological substances should be conducted in compliance with the principles of Good Laboratory Practice (“GLP”)

In the UK these requirements are contained within The Good Laboratory Practice Regulations 1999 as amended by The Good Laboratory Practice (Codification, amendments etc) Regulations 2004, collectively (“the Regulations”). The body which monitors the compliance of the regulations is the UK GLP Monitoring Authority.

The Regulations require that any test facility which intends to conduct regulatory studies must be a member of UK GLP Compliance Monitoring Programme.

The Regulations define a regulatory study as:

a) In which an item is examined under laboratory conditions or in the environment in order to obtain data on the properties or its safety (or both) with respect to Human Health, Animal Health or the Environment;

b) Where the results of which are or are intended to be submitted to the appropriate regulatory authorities:

c) Compliance with the principles of GLP is required in respect of that experiment or set of experiments by the appropriate regulatory authorities (whether or not compliance with the said principles in respect of that experiment or set of experiments is also a legislative requirement.

Further Information

MHRA: Good Laboratory Practice

OECD - Guidance Documents for Compliance Monitoring Authorities

MHRA - GLP: The UK GLP compliance monitoring programme