Control procedures: Good laboratory practice and quality assurance.

Abstract

Good Laboratory Practice (GLP) is one of the manifestations of the increased attention being paid to quality control measures in general. It provides a framework designed to bring the quality of laboratory results into accord with predefined standards and to maintain the quality at this level. The need for such a framework arises from the economic, political, and scientific implications that laboratory studies may have, which place demands on the reliability and comparability of the results. The value of Quality Control became clear in the 1950s during the reconstruction of Japanese industry, which had acquired a reputation for manufacturing cheap products of poor quality. During the reconstruction process, the work of Deming, an American pioneer in quality control, was used to advantage (20, 37). In the 1970s the U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) collaborated closely in the development of Good Laboratory Practice regulations (8, 13). The motive for developing such guidelines was the lack of reliable and comparable methods of obtaining results. In 1979 the principles of Good Laboratory Practice were made mandatory for U.S. Government contractors. During 1979/1980 in Europe a group of experts under the auspices of the Organisation for Economic Co-operation and Development (OECD) produced the document "OECD Principles of Good Laboratory Practice" (1). The purpose of this document was to promote the development of data of high quality, because good comparability of test data is a prerequisite to mutual acceptance of the data among countries. Legislation on this document was enacted in 1981 by members of the OECD. At first, the principles of Good Laboratory Practice were only prescribed for laboratories engaged in toxicological research for the pharmaceutical industry. Both the FDA and OECD guidelines mentioned above have this aim. Today the principles of Good Laboratory Practice have a wider scope. This overview provides a brief introduction to GLP and Quality Assurance. The aim of this paper is to give insight into the available literature on these topics. The several components of GLP and Quality Assurance are re- viewed but not discussed in detail. Detailed information is provided in the reference list.