The OECD Principles of Good Laboratory Practice establish the requirements for a quality assurance system implemented by test facilities in the conduct of non-clinical health and environmental safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drug products, food additives, feed additives, industrial chemicals, medical devices, and manufactured nanomaterials. The OECD Principles of Good Laboratory Practice are applied to those non-clinical health and environmental safety studies that are required by regulations for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals and manufactured nano materials. In many economies around the world, it is a legal requirement that such studies, when submitted as part of the dossiers for the pre-market approval of products, must have been conducted under Good Laboratory Practice (GLP).
Associated with such legal requirements is the need to verify compliance with these laws, and economies have established Compliance Monitoring Authorities (CMAs) to inspect facilities and audit studies to achieve this end. Test facilities are inspected and studies audited under a legal mandate, and failure of the test facility to accommodate such inspections and audits or to demonstrate compliance with GLP can result in rejection of the study for registration or licensing purposes (or in some circumstances be deemed to be a breach of the law).
Additional useful information on Good Laboratory Practice and the international acceptance of data generated under a GLP quality assurance can be found in the OECD webinar, OECD System of Mutual Acceptance of Data & Good Laboratory Practice (18 min)
IANZ is the national GLP Compliance Monitoring Authority for New Zealand, and will register test facilities that can demonstrate compliance with appropriate application the OECD Principles of Good Laboratory Practice.
The test items subject to the non-clinical health and environmental safety testing are frequently synthetic chemicals (or formulations thereof), but may be of natural or biological origin or may be living organisms or manufactured nano-materials. The purpose of the non-clinical safety testing on the test items is to obtain data (for regulatory registration or licensing purposes) on their properties and/or their safety with respect to human health and/or the environment
A Fee Schedule can be found under the Forms section on this page.
The types of non-clinical health and environmental safety studies covered by the OECD Principles of Good Laboratory Practice are typically from the following broad categories:
01 Physical – chemical testing
02 Toxicity studies
03 Mutagenicity studies
04 Environmental toxicity studies on aquatic and terrestrial organisms
05 Studies on behaviour in water, soil and air; bioaccumulation
06 Residues studies
07 Studies on effects on mesocosms and natural ecosystems
08 Analytical and clinical chemistry testing
09 Other specified studies.
It may include work conducted in laboratories, in greenhouses, and in the field. The test systems used (to which the test item is applied in order to assess or measure the effect) can be biological (e.g. in vivo testing in laboratory animals, in vivo testing in production animals in the field, in vitro testing in laboratory cultures, living plants in greenhouses or in the field), non-biological (e.g. soils, water and/or air in the laboratory or elsewhere) or may be laboratory instrumentation.
What constitutes a non-clinical health and environmental safety study (and thus within the scope of application of the OECD Principles of Good Laboratory Practice) is often the subject of debate and there is no definitive international agreement. Ultimately, it is the receiving authority, wherever it may be, that decides whether the data it requires for registration or licensing is to be generated under a quality system in compliance with the OECD Principles of Good Laboratory Practice.
