OECD principles of GLP

As a tool to make mutual acceptance of risk assessments possible, OECD has developed the concept of Good Laboratory Practice (GLP). The OECD Principles of GLP are an integral part of the 1981 OECD council decision on the Mutual Assessment of Data (MAD) in the Assessment of Chemicals (revised 1997, Section 2.2.2). MAD also harmonizes procedures of GLP compliance monitoring, ensuring that preclinical safety studies are carried out according to the principles of GLP and that countries can have conftdence in the quahty and rigor of safety tests. 

OECD Member States developed the OECD principles of GLP, utilising common managerial and scientific practices and experience from varions national and international sources. The purpose of these principles of good laboratory practice is to promote the development of quality test data. 

Currently 23 Indian laboratories have been accredited by the Indian national GLP compliance monitoring authority as per the provisions of the OECD Principles of GLP to conduct nonclinical health and environmental safety studies. The Indian system of GLP inspection, accreditation, and monitoring of test facilities was started in 2004 (India GLP). 

In addition to the development of the OECD Principles of GLP, the OECD Expert Group was given the responsibility of developing two additional guidance documents—one for the Implementation of OECD Principles of GLP and one as OECD Guidelines for National GLP Inspections and Study Audits. 

The Implementation document encourages member countries to adopt the OECD Principles of GLP into their legislative and administrative frameworks. As a part of the adoption and... 

OECD. No. 13 The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies, http //www.olis.oecd.org/olis/2002doc. nsf/LinkTo/env-jm-mono (2002) 9... 

The OECD Principles of GLP provide quality assurance concepts concerning the organization of test laboratories and the conditions under which laboratory studies are planned, performed, monitored, and reported. The purpose of the GLP Principles is to make certain that test data are reliable. Like the Test Guidelines, the Principles of GLP began to be developed at the end of the 1970s and were established in the 1981 Council Decision on MAD. 

The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies (2002). 

In 1981, the OECD Principles of GLP were finalized and led to the OECD Council Decision on the Mutual Acceptance of Data (MAD) which states that Data generated in the testing of chemicals in an OECD member country in accordance with OECD Test Guidelines and OECD principles of Good Laboratory Practice shall be accepted in other member countries for purposes of assessment and other uses relating to the protection of man and the environment . The OECD recommended in 1983 that implementation of GLP compliance should be verified by laboratory inspections and study audits. The EC later ratified the OECD principles and a number of Directives (e.g., 2004/9/EC, 2004/10/EC) indicates that tests must be carried out in compliance with the principles of GLP and that also that EU Member States must incorporate into their laws the requirement for all nonclinical safety studies to be conducted in compliance with GLP, and that premises conducting such studies must be inspected by a national authority. 

Firstly, why should, in these studies, certain adaptations in, and exceptions from, the general rules of the OECD Principles of GLP be necessary ... 

The OECD Principles of GLP provide a list of areas and topics for which SOPs should be written the list is expressly said to be non-exhaustive, but the various, illustrative examples provide test facilities (and SOP authors) with an... 

The OECD Council, in its Decision concerning the Mutual Acceptance of Data in the Assessment of Chemicals [C(8i)3o(Final)] , decided that data generated in one member country in accordance with OECD Test Guidelines and the OECD Principles of GLP should be accepted also in other member countries, with the intention that such studies would not need to be repeated, nor the GLP compliance of such studies be questioned. In an analogous way, in its Decision-Recommendation on Compliance with Principles of Good... 

GLP generally refers to a system of management controls for laboratories and research organizations to ensure the consistency and reliability of results as outlined in the Organisation for Economic Co-operation and Development (OECD) Principles of GLP and national regulations. Whereas the FDA and the U.S. Environmental Protection Agency (EPA) instituted GLP regulations, the OECD published GLP Principles in 1981, which now apply to the 30 member states of the OECD. 

Good Laboratory Practice (GLP) refers to a system of controls for laboratories conducting nonclinical studies to ensure the quality and reliability of test data as outlined in the OECD principles of GLP and national regulations, such as 21 CFR Part 58. 

A sub-chronic 13-wk oral toxicity study was performed on Clarinol G-80 in male and female Wistar outbred (Crl (WI)WU BR) rats (5). The study was conducted in accordance with the OECD principles of GLP and in accordance with OECD guideline 408 (adopted 1998). 

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