Good Laboratory Practice

In 1981 the Organisation for Economic Co-operation and Development (OECD) principles of Good Laboratory Practice (GLP) were finalised and led to the OECD Council Decision on the Mutual Acceptance of Data (MAD): 'Data generated in the testing of chemicals in an OECD member country in accordance with OECD Test Guidelines and OECD principles of Good Laboratory Practice shall be accepted in other member countries for purposes of assessment and other uses relating to the protection of man and the environment.' At a meeting in 1983, concerning the mutual recognition of compliance with GLP, the OECD recommended that implementation of GLP compliance should be verified by laboratory inspections and study audits.

The European Community (EC) later adopted the OECD principles and a number of Directives stipulate that tests must be carried out to the principles of GLP and also that EC Member States must incorporate into their laws the requirement for all the non-clinical safety studies which are listed in the sectoral Directives, to be conducted to GLP and that premises conducting such studies must be inspected by a national authority. Consequently, on 1 April 1997 there came into force in the UK a Statutory Instrument (SI) entitled 'The Good Laboratory Practice Regulations 1997' which superseded the voluntary United Kingdom Good Laboratory Practice Compliance programme. In 1998 the OECD issued the revised Principles of GLP and Compliance Monitoring. These were adopted by the EC in October 1998 and issued as Directives 99/11/EEC and 99/12/EEC. Consequently, in 1999, the UK Regulations were updated by SI 3106, as amended by SI 994, 2004, and are accompanied by a guide that interprets them and explains how compliance will be verified.

Definition of Good Laboratory Practice
Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. 

Contacts for further information
Any enquiries concerning GLP or related matters should be sent to the GLP Monitoring Authority at glp@mhra.gsi.gov.uk

Any enquiries concerning a specific GLP inspection, please contact the appropriate inspector:

Andrew Gray - andrew.gray@mhra.gsi.gov.uk
Steve Monk - steve.monk@mhra.gsi.gov.uk
Lesley Graham - lesley.graham@mhra.gsi.gov.uk
Mary Baynes - mary.baynes@mhra.gsi.gov.uk
Samantha Atkinson - samantha.atkinson@mhra.gsi.gov.uk
Christine Burwood - christine.burwood@mhra.gsi.gov.uk