| Автор | Falconi, Giovanni |
| Автор | Christian, Mildred S. |
| Дата выпуска | 1990 |
| dc.description | 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.<sup>||</sup> 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. |
| Формат | application.pdf |
| Издатель | Taylor & Francis Group |
| Копирайт | Copyright Taylor and Francis Group, LLC |
| Название | An overview of GLP implementation in Europe |
| Тип | other |
| DOI | 10.1080/08989629008573782 |
| Electronic ISSN | 1545-5815 |
| Print ISSN | 0898-9621 |
| Журнал | Accountability in Research |
| Том | 1 |
| Первая страница | 107 |
| Последняя страница | 110 |
| Аффилиация | Falconi, Giovanni; Farmitalia Carlo Erba |
| Аффилиация | Christian, Mildred S.; Argus Research Laboratories, Inc. |
| Выпуск | 2 |
| Библиографическая ссылка | EEC Directive 88/320/EEC (1988). Official Journal of the European Communities. No. L. 145/35, II. |
| Библиографическая ссылка | U.S. Food and Drug Administration. 1987. Good Laboratory Practice Regulations: Final Rule. Federal Register, Friday September 4 1987 Part VI, Vol. 52, No. 172 |
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| Библиографическая ссылка | Environmental Protection Agency. 1983. Toxic Substances Control; Good Laboratory Practice Standards: Final Rule. Federal Register, 48(230) Part III |
| Библиографическая ссылка | Environmental Protection Agency, Washington, D.C., Federal Register Monday, December 28, 1987, Vol. 52, No. 248, Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and Toxic Substances Control ACT (TSCA); Good Laboratory Practice Standards; Proposed Rules. |
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| Библиографическая ссылка | 87/C 13/06 (1987). Commission. COM(86) 698 final. II. 4 pp. |
