Good Laboratory Practice

Health and environmental safety data are required for the registration of a wide range of product types and product registration is usually sought in more than one country.

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) which states that “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 Commission (EC) later ratified 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 non-clinical safety studies to be conducted in compliance with 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came into force in the UK a Statutory Instrument (SI) entitled 'The Good Laboratory Practice Regulations 1997' which superseded the existing voluntary United Kingdom Good Laboratory Practice Compliance programme.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 1999/11/EC and 1999/12/EC which amended the existing directives which were 87/18/EEC and 88/320/EEC. Consequently, in 1999, the UK Regulations were also 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.

Since publication of the UK regulations the original EU Directives have been replaced by the codified directives 2004/9/EC which relates to inspection of facilities and verification of GLP compliance, and 2004/10/EC which describes the principles themselves.