The Revised Principles of Good Laboratory Practice of the Organisation for Economic Cooperation and Development-Changes,Chances,and Controversies *

Abstract

This paper is the condensed result of the presentations and discussions held at the DIA Workshop “The Revised OECD Principles of Good Laboratory Practice,” held September 3 and 4, 1998, in Brussels. The workshop brought together inspectors from compliance monitoring authorities and quality assurance units in industry, as well as study directors working according to the rules of Good Laboratory Practice (GLP). They discussed a number of issues important to the successful implementation of the revised Principles of Good Laboratory Practice of the Organisation for Economic Cooperation and Development (OECD), were informed about the changes which had taken place in this set of rules, debated areas of controversy, and looked at opportunities in the revised principles to improve the quality of safety studies. Specific areas covered included the new definitions given in the revised principles and their pragmatic application, the question of whether the new position of the principal investigator would offer any benefits to the procedures in the pharmaceutical industry, the issue of what constitutes a short-term test and how a test facility and its quality assurance unit could sensibly deal with it, and the impact of information technology, including the possibility of electronic signatures on Good Laboratory Practice and its implementation in the future. There are no easy solutions or handy recipies for any of the issues tackled in these discussions, nor were they expected. The result of the workshop was a better understanding of the various viewpoints that could be taken when it comes to interpreting and implementing the Principles of Good Laboratory Practice. The rules governing this quality system are general terms which must be adapted in a pragmatical manner to widely differing situations, and a workshop such as this can help to bridge the gaps between this wide array of disciplines working under GLP. In this, the DIA Workshop on the “The Revised OECD Principles of Good Laboratory Practice” succeeded in full measure.

Keywords

Study Definitions Responsibilities Short-term studies Sponsor Principal investigator Information technology Validation

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References

OECD Principles of Good Laboratory Practice (as revised in 1997), OECD Environmental Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 1. Paris: Organisation for Economic Cooperation and Development; 1998.

The Application of the GLP Principles to Field Studies, GLP Consensus Document, OECD Environmental Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 6. Paris: Organisation for Economic Cooperation and Development; 1992.

The Role and Responsibility of the Sponsor in the Application of the Principles of GLP, Advisory Document of the Panel on Good Laboratory Practice, OECD Environmental Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 11. Paris: Organisation for Economic Cooperation and Development; 1998.

Electronic Records; Electronic Signatures; Final rule (21 CFR Part 11), US Department of Health and Human Services, Food and Drug Administration. Federal Register, Vol. 62, No. 54, Thursday March 20, 1997, p. 13429 ff.