An overview of GLP implementation in Europe†

Presented at the First International Conference on Scientific Data Audit Policies and Quality Assurance May 8–10, 1988. Some information contained in this publication was initially presented by Dr. Falconi at the 1987 Society of Quality Assurance Association meeting and will be published.

Abstract

GLP Regulatory Requirements in Europe are dependent upon and reflect multiple issues. These issues include EEC mandates, requirements of specific European countries that are not EEC Members, and economic ties with non‐European countries.

In 1987, three EEC directives were issued, and a fourth directive was proposed.^|| Under these directives, it will be necessary to perform safety evaluations of chemical substances, medicinal products and veterinary products in compliance with “Good Laboratory Practices Principles”; (GLPs), after legislative acceptance of the directives by the individual member countries. These three EEC directives provide for the following procedures: 1) each member country will perform its own inspections and audits; 2) the EEC commission will distribute information regarding GLP compliance; and 3) after a successful inspection, laboratories will receive certification of GLP compliance. The fourth (proposed) directive is designed to: 1) aid in harmonization of inspections; 2) unify the criteria for evaluation; 3) introduce GLP certification for specific test methods; and 4) institute a Technical Committee or a mechanism for adapting the directive to technological progress.

Notes

Presented at the First International Conference on Scientific Data Audit Policies and Quality Assurance May 8–10, 1988. Some information contained in this publication was initially presented by Dr. Falconi at the 1987 Society of Quality Assurance Association meeting and will be published.