What is GLP?
It is important that we understand what is meant by the term "GLP" and that we know what to look for when a "GLP" facility is required or claimed.
Why Should I Seek GLP Recognition with NATA?
Any facility claiming to be compliant with the Principles of Good Laboratory Practice of the Organization for Economic Cooperation and Development (OECD) under the Australian GLP compliance monitoring program must be recognised by NATA for that compliance. While some organisations claim to offer a GLP "certification", these "certifications" have no standing internationally as a demonstration of GLP compliance under a national program and the mutual acceptance of data.
Under a 1981 decision of the OECD Council, data generated in an OECD member country under its national compliance monitoring program is accepted in other OECD member countries for the purposes of product registration (Mutual Acceptance of Data). To this end NATA reports annually to the other national GLP compliance monitoring authorities, detailing the facilities currently in the Australia program and their current GLP compliance status.
As of January 2003, the APVMA (Australian Pesticides and Veterinary Medicines Authority), formerly the NRA (National Registration Authority), has mandated that all residue studies must be done in compliance with the OECD Principles of Good Laboratory Practice. Further details, including exemptions to this requirement, can be found in the NRA Gazette No3, 5 March 2002.
What Are the OECD Principles?
The basic document dealing with GLP is the OECD Principles of Good Laboratory Practice, published by the OECD's Environment Directorate, and most recently revised in 1998. This document is produced by the OECD GLP Working Group, on which Australia is represented by NATA as the national GLP compliance monitoring authority, recognised as such by NATA's Memorandum of Understanding with the Commonwealth Government. Some national monitoring authorities issue their own versions of the OECD Principles (e.g. USFDA, USEPA, various Japanese ministries) but the OECD Principles of GLP are the foundation of these other documents that may be issued as part of national legislation.
Facilities in Australia producing data that will be presented in the US, Japan or any other OECD member country must comply with Australian requirements, not those of the receiving country. In other words, Australian facilities do not have to test to the USFDA document.
The basis for the development of GLP was to provide assurance regarding test data from non-clinical studies related to the hazard assessment of chemicals (pharmaceuticals, veterinary and agricultural chemicals, identical chemicals) when manufacturers are seeking to register products for use. In Australia, the relevant registration authorities are the Therapeutic Goods Administration (TGA) (for pharmaceuticals), the National Registration Authority (NRA) (for veterinary and agricultural chemicals), and the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (for industrial chemicals).
How Do I Apply the GLP Principles?
The Principles of GLP are applied to the conduct of non-clinical health and environmental safety studies of test items contained in various chemical products. A study covers work done in a laboratory, in an animal house, in greenhouses, and in the field. The Principles of GLP do not apply to clinical studies (including pharmaco-kinetic and efficacy studies). Non-clinical studies may cover physico-chemical testing; toxicity, mutagenicity, environmental toxicity, bioaccumulation and residue studies; studies of effect on mesocosms and ecosystems, and the analytical chemistry associated with such studies.
GLP is a quality system concerned with the organisational process and the conditions under which non-clinical studies are planned, performed, recorded, archived and reported. It does not concern itself with the technical validity of the studies themselves. This aspect of a study is evaluated by the registration (receiving) authority. The Principles can be quite prescriptive about some aspects of the conduct of the studies, especially in relation to the role of the Study Director (and any Principal Investigators), the role of the Quality Assurance unit, the documenting of Standard Operating Procedures (SOPs), the content of study plans (protocols) and reports, and the way in which all data related to each study is archived.
What About GLP and Clinical Studies?
There is a misconception in some quarters that GLP is required for the conduct of clinical studies. This is not correct. The introduction to the OECD Principles of GLP (and the introduction to the USFDA GLPs in 21CFR part 58) make clear that they apply only to non-clinical (pre-clinical) studies. The relevant documents for clinical studies are the various codes of GC(R)P (e.g. ICH; TGA). The USFDA and other registration authorities do require a demonstration of the quality of test data from clinical studies. In the US this may well be by means of conformance with CLIA (Clinical Laboratories Improvement Act). In Australia, this is best demonstrated by the testing laboratory's NATA accreditation (in Medical Testing, Chemical Testing, etc).
How Can I Gain GLP Recognition?
In brief, a facility seeking recognition for compliance with the OECD Principles of GLP should apply to NATA for GLP Recognition, stating the proposed scope of the recognition - types of studies, etc. An on-site assessment is done to determine compliance with the Principles. At least one GLP compliant study must be completed prior to the initial assessment, as a component of the assessment is the audit of completed studies.
Reassessments are done every two years and a study audit is done annually.
Where Can I Access the OECD Principles of GLP?
Copies of the OECD Principles of GLP and useful guidance documents can be downloaded from the OECD website.
What are the Responsibilities of a Sponsor of GLP studies?
Full details on the responsibilities of sponsors can be found in the document Information for GLP Study Sponsors.
Where Can I Get More Information?
Further information on the Australian compliance monitoring program can be found in the document About NATA and GLP Recognition.