The Application of the Principles of GLP to in vitro Studies

As efforts to decrease the use of animals in safety testing are intensifying, in vitro methods are gaining a more prominent role as alternatives or supplements to in vivo safety testing. Anticipated developments in the fields of toxicogenomics, toxicoproteomics, toxicometabonomics and in various high through-put screening techniques are expected to enhance the importance of in vitro methodologies for safety testing, beyond their traditional use as test systems in the area of genetic toxicity testing. The OECD Working Group on Good Laboratory Practice considered it therefore worthwhile to develop further guidance specifically of relevance to the application and interpretation of the OECD Principles of GLP to in vitro studies.

The Working Group established a Task Force under the leadership of Switzerland, which met in Bern on 12 to 13 February 2004. The Task Force comprised members of the Working Group or experts in in vitro testing nominated by them representing Belgium, France, Germany, Japan, the Netherlands, Switzerland, the United States and the European Commission.

The draft Advisory Document developed by the Task Force was examined by the Working Group at its 18th Meeting in May 2004, where it was amended and endorsed. The Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology at its 37th Joint Meeting in turn endorsed the document and recommended that it be declassified under the authority of the Secretary-General.

Quelle: Organisation for Economic Co-operation and Development (OECD)