Part A REVISED GUIDES FOR COMPLIANCE MONITORING PROCEDURES FOR GLP

To facilitate the mutual acceptance of test data generated for submission to Regulatory Authorities of the OECD member countries, harmonisation of the procedures adopted to monitor GLP compliance, as well as comparability of their quality and rigour, are essential. The aim of this part of this Annex is to provide detailed practical guidance to the Member States on the structure, mechanisms and procedures they should adopt when establishing national GLP compliance monitoring programmes so that these programmes may be internationally acceptable.

It is recognised that Member States will adopt GLP principles and establish compliance monitoring procedures according to national legal and administrative practices, and according to priorities they give to, for example the scope of initial and subsequent coverage concerning categories of chemicals and types of testing. Since Member States may establish more than one GLP Monitoring Authority due to their legal framework for chemicals control, more than one GLP compliance programme may be established. The guidance set forth in the following paragraphs concerns each of these Authorities and compliance programmes, as appropriate.