Good Laboratory Practice CLP

Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Adherence by test facilities to the principles of GLP ensures that there is a proper plan- 

The OECD has produced an internationally accepted set of Principles of Good Laboratory Practice in order to promote the development of quality test data. These have been ratified by the European Commission and transposed into EC Directives. 

Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these Principles helps to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment. 

The Manager of a testing laboratory is responsible for ensuring that the Principles of Good Laboratory Practice are complied with in the facility. The OECD has set down the minimum responsibilities, which should be to 

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If the bioanaiyticai method is performed according to good laboratory practice (CLP), the method is described in a standard operating procedure (SOP) and the validation method is reported accordingly. In general, validated methods are used in preclinical development for toxicokinetic studies and in clinical development for all studies in which pharmacokinetics is evaluated. 

OECD Series on Principles of Good Laboratory Practice and Compliance monitoring. Number 1 CLP Consensus Document The OECD Principles of Good Laboratory Practice. Environment Monograph No. 45, Paris 1992. 

CLP (Good Laboratory Practice). 2006. Organisation for Economic Co-operation and Development, Paris. Available from http //www.oecd.org/department/0,2688,en 2649 34381 l l l l l,00.html... 

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