OECD Good Laboratory Practice

IANZ is the Government appointed National GLP Compliance Monitoring Authority for New Zealand. Testing facilities are inspected for compliance with the OECD Principles of Good Laboratory Practice and related consensus documents. Copies of these documents are available at no charge from the OECD website.

Registration Criteria
The primary criteria document against which all GLP Compliant test facilities are assessed is:
Number 1: The OECD Principles of Good Laboratory Practice (1998).

Scope

The scope of application of the OECD Principles is restricted to non-clinical safety testing of test items contained in:

  • Cosmetic products
  • Feed additives
  • Food additives
  • Industrial chemicals
  • Pesticide products
  • Pharmaceutical products
  • Veterinary drugs

These items are tested for their properties and/or safety with respect to human health and/or the environment. The non-clinical health and environmental safety studies are intended for submission to regulatory or receiving authorities for the purpose of registering or licensing pharmaceutical, pesticide, food or feed additive, cosmetic or veterinary drug products; or for regulating industrial chemicals. IANZ will grant a GLP compliance registration for these types of studies and for the purposes indicated.

These items are tested for their properties and/or safety with respect to human health and/or the environment. The non-clinical health and environmental safety studies are intended for submission to regulatory or receiving authorities for the purpose of registering or licensing pharmaceutical, pesticide, food or feed additive, cosmetic or veterinary drug products; or for regulating industrial chemicals. IANZ will grant a GLP compliance registration for these types of studies and for the purposes indicated.

Test categories
Typically, non-clinical safety tests fall into the following categories:

  • Physical-chemical testing
  • Toxicity studies
  • Mutagenicity studies
  • Environmental toxicity studies on aquatic and terrestrial organisms
  • Studies on behaviour in water, soil and air
  • Residue studies
  • Studies on the effects on mesocosms and natural ecosystems
  • Analytical and clinical chemistry testing

Other types of trials on test items (such as clinical trials) related to non-safety testing (e.g. efficacy) are outside the scope of application of the IANZ GLP Compliance Monitoring Programme.

Regulatory requirements
Many economies within the OECD mandate GLP compliance statements accompanying the submission of such data. New Zealand regulatory authorities do not currently require such studies to be conducted in accordance with Good Laboratory Practice.

The Ministry for Primary Industry (MPI), Agricultural Compounds and Veterinary Medicines (ACVM) Group (the New Zealand regulatory authority for pesticide products, veterinary drugs and feed additives) require GLP compliance for residue studies. For further information see the MPI website.