Abstract
GLP implementation in Europe is complicated by a “diversified” approach. European toxicology testing facilities must be aware not only of their own national regulations but also of the requirements of other European countries as well as several significant non-European nationalities (the United States and Japan). This presentation briefly describes four EEC directives pertaining to GLP implementation in Europe.
These directives provide for (1) performance of audits and inspections by member states; (2) EEC distribution of information regarding GLP compliance; (3) harmonization of inspections and unification of criteria; (4) certification of GLP compliance; and (5) provision of mechanisms to adapt the directives to technical progress.
References
1.
1. OECD Principles of Good Laboratory Practice (1981). Good Laboratory Practice in the Testing of Chemicals, Final Report of the Oecd Expert Group on Laboratory Practice (ISBN 92–64–12367–9).
2.
2. Eec Directive 87/18/EEC (1987). Official Journal of the European Communities. No. L 15/29, Ii. 17/1.
3.
3. Eec Directive 87/19/EEC (1987). Official Journal of the European Communities. No. L 15/29, Ii. 17/1.
4.
4. Eec Directive 87/20/EEC (1987). Official Journal of the European Communities. No. L 15/29, Ii. 17/1.
5.
5. Eec Directive 79/831/EEC (1979). Official Journal of the European Communities. No. L 259/10–28 (“Sixth Amendment”).
6.
6. Eec Directive 75/318/EEC (1975). Official Journal of the European Communities. No. L 147, 9/6.
7.
7. Eec Directive 81/852/EEC (1981). Official Journal of the European Communities. No. L 317, 6/11.
8.
8. Eec Directive 88/320/EEC (1988). Official Journal of the European Communities. No. L 124/35, Ii.
9.
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