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Establishment and Control of Archives that Operate in Compliance with the Principles of GLP


The OECD Working Group on Good Laboratory Practice, at its 17th meeting in 2003, established a drafting group under the leadership of the Netherlands (Mr. Theo Helder), with participation by Germany, Italy, Sweden, Switzerland the United Kingdom and the United States. After reviewing existing material on archiving in a GLP environment, the group develop a first draft document, which was reviewed by the Working Group at its 20th meeting in 2006.

The Working Group agreed that it would circulate the draft for comment to stakeholders in industry and receiving authorities and that Members would prepared consolidated national comments. Comments were received from Australia, Belgium, Denmark, Finland, Germany, Ireland, Israel, Italy, Japan, Korea, Netherlands, Slovenia, Spain, Sweden, Switzerland, and United States.

The Working Group then reviewed, amended and endorsed a revised version of the document at its 21st Meeting in 2007. The Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology endorsed the document on 25 May 2007and agreed that it be declassified and published in the OECD series on GLP and Compliance Monitoring as an Advisory Document of the Working Group on GLP.

Source: OECD