EC updates Directive for checks on good laboratory practice
The European Commission (EC) has recently published a Directive (1999/12/EC), which brings up to date a previous EC ruling on the inspection and verification of Good Laboratory Practice (GLP). This has been published in parallel with amendments to existing regulations on the applications of the principles of GLP. The Directive adapts for a second time, the Annex to Council Decision 88/320/EEC, which is now published in full to facilitate uniform interpretation of the amendments. According to the Commission, compliance and comparability of the quality and vigour of test data generated for submission to the regulatory bodies of the OECD (Organisation for Economic Cooperation and Development) member countries are essential, and the new guidelines are intended to assist the mutual acceptance of such data. The provisions for the inspection and verification of GLP are divided into two parts in the Annex. Detailed practical guidance to Member States is given in Part A of the Annex, on the structure, mechanisms and procedures they should adopt when establishing national GLP compliance-monitoring programmes to internationally acceptable standards. Part B of the annex provides guidance for the conduct of test-facility inspections and study audits, which would be mutually acceptable to OECD member countries. A test-facility inspection will usually include a study audit or review as a part of the inspection, but study audits will also have to be conducted from time to time at request of the appropriate regulatory bodies. General guidance on the conduct of study audits is also included in the annex. The Member States are required to adopt this legislation by 30 September 1999.