Comparison Between the 1992 Principles of Good Laboratory Practice as Defined in the Environment Monograph No. 45 and the Draft Revision of the Principles of GLP as Published by OECD on 6 January 1997

Abstract

Whilst it is accepted that the draft revised OECD Principles, which were developed in 1995 and 1996 by the Expert Group, has been put out to industry for review, it is likely that the changes, following the review period, will not be of any great significance or difference from that document which has been provided to industry. In fact, in the covering letter that accompanies the OECD draft Revision from the Environmental Health and Safety Division, there was a paragraph which indicated ‘those issues for which consensus could not be reached were not included in the draft Revision’. This indicates that there are some areas where it will be impossible for harmonization to be achieved and, in general, it is thought that with the expansion of the GLPs there is very little in terms of contentious issues which will be seen by industry as an imposition on the current use of the GLPs and the implementation of these in non-clinical safety studies. The following personal viewpoint therefore is a summary of the changes and a comparison between the two guidelines which it is hoped will give the reader immediate information as to where changes have occurred and the implication of those changes for the personnel involved in non-clinical safety studies.