GLP Organisation for Economic Cooperation & Development (OECD) Principles of Good Laboratory Practice (GLP)

The OECD Principles of GLP cover the organisational processes and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported, and retained.

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What are the OECD Principles of GLP?

The OECD is an international organisation that works to establish evidence-based international standards and find solutions to a range of social, economic and environmental challenges.

The OECD Principles of GLP are applicable to test facilities performing (non-clinical) studies that will be submitted to authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products.

They also define the responsibilities of test facility management, study director, study personnel and quality assurance personnel operating within a GLP system. In addition, standards concerning the suitability of organisations and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports and the archiving of records.

Why are OECD Principles of GLP important?

The OECD Principles of GLP ensure the generation of high quality and reliable test data related to the safety of test items such as pharmaceuticals, pesticides and veterinary drugs. The principles have been created in the context of harmonising testing procedures for the Mutual Acceptance of Data (MAD).

This process also ensures that duplicated testing and barriers to trade can be avoided, time and resources saved, all while improving the protection of human health and the environment.

What industries are suitable for GLP recognition?

Australian recognition by NATA for compliance with the OECD Principles of GLP is available to any Australian facility performing non-clinical health and environmental safety studies for regulatory purposes.

GLP recognition is available for the agribusiness (pesticides; herbicides; veterinary chemicals), pharmaceutical, food, medical devices, cosmetic and industrial chemicals sectors.

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FAQs

The MAD system helps to avoid conflicting or duplicative national requirements, provides a common basis for co-operation among national authorities and avoids creating non-tariff barriers to trade.

OECD countries to the relevant OECD Council Acts have agreed that studies carried out in accordance with the OECD Test Guidelines and Principles of Good Laboratory Practice in one OECD country must be accepted by other countries which adhere to MAD for assessment purposes. This is the concept of “tested once, accepted for assessment everywhere. *” This saves the chemical industry the expense of duplicate testing for products which are marketed in more than one country. 

*While the receiving government must accept the study, how it interprets study results is its own prerogative.

The NATA Accreditation Criteria (NAC) packages are made up of numerous documents which are available for download.

There are General Accreditation Criteria which apply to all facilities, and Specific Accreditation Criteria tailored for industry sectors and activities.

  1. General NATA Documents
  2. General Accreditation Criteria
  3. Specific Accreditation Criteria

General Accreditation Guidance and Specific Accreditation Guidance documents present information on common technical or operational issues.

  1. General Accreditation Guidance
  2. Specific Accreditation Guidance
  3. General Accreditation Forms

Documents published by the OECD are available from https://www.oecd.org/chemicalsafety/testing/good-laboratory-practiceglp.htm

NATA Accreditation Criteria (NAC) Package

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