The OECD Principles of Good Laboratory Practice (GLP) ensure the generation of high quality and reliable test data related to the safety of industrial chemicals. The Principles have been created in the context of harmonising testing procedures and study conduct and are pivotal to the Mutual Acceptance of Data (MAD) agreement. This agreement assists with the exchange of data between regulators and reduces the need for duplicate testing.
The OECD Principles of GLP are a quality assurance system implemented by test facilities engaged in non-clinical health and environmental safety studies for regulatory purposes. These studies are conducted on various test items found in pharmaceuticals, pesticides, cosmetic products, veterinary drugs, food additives, feed additives, industrial chemicals, medical devices, and other chemicals such as manufactured nanomaterials.
In most OECD members and some other economies, it is a legal requirement that such studies, when included in pre-market approval dossiers are conducted in accordance with the OECD Principles of (GLP). And, as part of the MAD agreement, authorities have been established in these economies to monitoring compliance with the Principles. These compliance monitoring authorities (CMAs) inspect facilities and audit studies to verify adherence to the Principles. Failure of a test facility to accommodate such inspections and audits, or to demonstrate compliance with GLP, can lead to the rejection of the study for registration or licensing purposes.
NATA is appointed by the Australian Government as the national GLP CMA and represents Australia at the OECD Working Party on GLP. NATA also recently underwent a successful on-site evaluation visit conducted from 14 – 18 August 2023 by members of the Working Party. Such visits increase confidence in MAD and builds trusts between CMAs and regulators.
NATA would like to extend a heartfelt thanks to all the NATA staff who participated in the evaluation activities as well as to the facilities who hosted the evaluation team for the witnessing of assessments.