Australasian Biotechnology, Vol. 12 No. 1, 2002, pp. 19

BIOTECH LABORATORY PRACTICE

WHAT IS GLP?

Louise Calder, GLP Program Manager, NATA, Sydney

Code Number: au02004

Introduction

The term ‘good laboratory practice’ has numerous meanings depending on whether you are a laboratory research organisation, sponsor or regulatory authority. Clients of laboratories will often request that their work be done using ‘good laboratory practice. Organisations will often claim that they are working ‘under glp’. Regulatory authorities and other agencies responsible for registering and controlling chemicals and pharmaceuticals may request that a laboratory demonstrate that data included in a registration package for a new chemical have been gathered using ‘good laboratory practice’. They may also require that organisation to be ‘certified’ (or accredited) by a third party for ‘GLP’. It is therefore important that all interested parties understand what is meant by this term and what to look for when a ‘GLP’ facility is required or claimed.

Iris hoped, of course, that all laboratories follow ‘good laboratory practice’; however, this term has a specific meaning when applied to non-clinical environmental health and safety studies. In this case, ‘GLP’ refers to the OECD Principles of Good Laboratory Practice, which were developed in the late 1970s to promote the development of quality test data associated with non-clinical studies. They also form the basis for the mutual acceptance of test data from such studies amongst OECD countries.

These Principles define and describe a quality system concerned with the organisational processes and conditions under which a non-clinical health and environmental safety study is conducted. Conversely, clinical studies should be conducted using the GCP (Good Clinical Practice) guidelines. Accreditation to ISO IEC 17025- 1999 General requirements for the competence of testing and calibration laboratories is the appropriate standard for laboratories performing routine testing including that associated with clinical trials.

GLP Monitoring in Australia

Although it is possible for organisations to claim they are following ‘GLP’ (and to make self declarations to this effect in their reports), only those facilities accredited by the National Association of Testing Authorities, Australia (NATA) for GLP can daim to be GLP­compliant under the Australian compliance monitoring scheme. A list of GLP-accredited facilities and their scope of recognition can be obtained from the NATA website at www.nata.asn.au.

NATA is the Australian organisation responsible for monitoring compliance within the OECD Principles of Good Laboratory Practice. It is also the organisation responsible for international liaison on OECD GLP compliance monitoring issues. This is recognised in a Memorandum of Understanding (MOU) signed between the Commonwealth of Australia and NATA (available from the ‘publications’ section of the NATA website.

All organisations are assessed by NATA against the OECD Principles of Good Laboratory Practice and interpretative criteria that are defined in NATA’s publication OECD Principles of GLP Interpretation. In addition, organisations must comply with NATA’s Rules, which include formal requirements for maintenance of appropriate professional conduct by the organisation.

While compliance with the OECD Principles of GLP is currently not mandatory in Australia, a number of organisations in Australia have initiated studies in compliance with the Principles to meet client demands overseas. In addition, the National Registration Authority (NRA) has resolved that, from 31 December 2002, all residue studies must be GLP­compliant.

The Australian program is open to facilities performing non-clinical studies on a wide range of test items. The scope of each accreditation by NATA is defined by the categories of test items and types of studies performed on them. These studies willfall into one of the following categories:

Only organisations that are accredited with NATA for GLP compliance are allowed to use the NATA endorsements on their reports. For a study to be claimed to be compliant under the Australian GLP compliance monitoring program the study director’s statement in a report must include this endorsement as shown below:

Organisations should look for this endorsement as an indication that the study had been conducted to ‘GLP’ under the Australian GLP Program. They can also contact NATA to confirm the scope of accreditation for any facility or visit the NATA website for these details.

Further information on the GLP program and the monitoring of compliance with OECD Principles of GLP in Australia can be obtained from:

Ms Louise Calder, GLP Program Manager Tel: (02) 9736 8222; email: Louise.Calder@nata.asn.au

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