Quest for harmonisation: differences and similarities in national programmes for GLP monitoring. A senior inspector's viewpoint.
The conditions under which safety data may be accepted by regulatory authorities (RAs) in OECD Countries do not only include the obligation to apply the principles of good laboratory practice (GLP) while producing these data, but also must countries, partaking in the Organisation for Economic Cooperation and Development (OECD) system for mutual acceptance of data (MAD), establish a monitoring programme to ensure proper application of the GLP principles. Detailed guidance to this end is given in the OECD GLP documents No. 2 and 3. Nevertheless, this guidance permits countries quite some freedom where it concerns the organisation of their programmes. Monitoring programmes may be embedded in governmental as well as private structures. It appears that GLP compliance monitoring is increasingly charged to accreditation bodies. Inspectors may be full-time or part-time workers, and there are differences in scheduling and performing inspections and study audits. Also the financing of the monitoring programmes is diverging: in some countries the programme is fully or partly paid by the inspected test facilities (TFs), while in other countries the financing comes from the national treasury. Is there a need for harmonisation in this area, as there is and was in the interpretation of the GLP principles themselves? Over the years more than ten consensus and advisory documents have been published by the OECD working group on GLP. The very existence of these documents is however no guarantee that the interpretation of the GLP principles by inspectors is similar, let alone identical. The most important criterion is, in fact, that there be no harm for human health and the environment.
Helder
Theo
T
Food and Consumer Products Safety Authority, Inspectorate for Health Protection, The Hague, The Netherlands. theo.helder@vwa.nl
D019411:Clinical Laboratory Techniques / Q000592:standards*; D004467:Economics; D019983:Guideline Adherence; D017408:Guidelines as Topic; D007390:International Agencies; D011786:Quality Control