A New International Perspective—The Application of the Principles of GLP to Computerized Systems (OECD 1995)

Abstract

The Organisation for Economic Cooperation and Development (OECD) is a Paris-based intergovernmental organization grouping 27 industrialized countries, including the United States, Japan, and all (15) Member States of the European Union. OECD has been involved in the harmonization of policies and programs for chemicals control since the late 1970s. The OECD guidelines for both the testing of chemicals and the principles of good laboratory practice were both developed in the broader context of mutual acceptance of data. The 1982 OECD Principles of GLP have been adopted by many countries and were adopted per se by the European Community (now European Union) by way of Directive 87/18/EEC in December 1988.

One of the OECD's most important activities in the past decade has been to promote international harmonization of the whole GLP system—including the GLP principles, their effective implementation, the performance of national compliance monitoring programs, the information exchange between national monitoring authorities, and the mutual acceptance of data (MAD). Currently, the OECD's work on GLP is directed primarily at the information exchange aspect of mutual recognition. This is done through various fora and mechanisms under the auspices of the OECD panel on GLP, which comprises representatives from national monitoring authorities. Probably the most important fora are the so-called “Consensus Workshops” aimed at reaching a common understanding of the GLPs and their application and interpretation. The workshops are attended by representatives of both national monitoring authorities and industry. The expected product of such workshops is a consensus document which, following extensive peer reviews and acceptance procedures, is endorsed by the OECD Environmental Policy Committee and published by the OECD as one in a series of GLP monographs.

This paper briefly considers the process by which the most recent consensus document on “The Application of the Principles of GLP to Computerized Systems” was developed by OECD, and then more fully discusses some of the more important considerations within its content, including the scope of systems, responsibilities, validation, data, documentation, and standard operating procedures.