Las prácticas correctas de laboratorio y problemas en su implantación

  1. Guillermo Repetto 1
  1. 1 Instituto Nacional de Toxicología y Ciencias Forenses
    info

    Instituto Nacional de Toxicología y Ciencias Forenses

    Las Rozas de Madrid, España

Revista:
Revista de toxicología

ISSN: 0212-7113

Any de publicació: 1988

Volum: 5

Número: 1-3

Pàgines: 117-125

Tipus: Article

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Altres publicacions en: Revista de toxicología

Resum

Good Laboratory Practice (GLP) tries to ensure the quality of toxicity tests by means of the application of a series of measures which potentiate transparency at every stage of their development. Since they were mentioned for the first time in a book of regulations in New Zeeland in 1972, they have evolved enormously: They were promulgated as laws initially by the American FDA and soon after by the ERA and Japan, with several variations, the unification of criteria of which has been impelled by the OECD and the EEC, giving fruit in national legislations. Besides establishing the differences between the present regulations, different aspects and practical problems appearing when an investigation centre initiates the process of implementation of said regulations are conmmented.

Referències bibliogràfiques

  • BERLÍN, A.; ROÍ, R.; Van Der VENNE, M.T. y WENNING, R.: Compendium of Toxicological Testing Facliities in the European Communities, Commission of the European Communnities EUR 11547, EN, 1988.
  • DENMARK: Danish National TestingBoardAct, 144,1973.
  • ECETOC: GoodLaboratoryPractice, Monograph 1, Brussels, 1979.
  • EEC: Council Directive 87/18/EEC on the harmonization of the laws, regulations and administrative provisions relating to the application of the Principies of Good Laboratory Practice and the verification oftheir application fortests on chemical substances, OJEC L15,17.1.1 87, Brussels, 1987.
  • EEC: Directiva del Consejo 87/19/CEE por la que se modifica la Directiva 75/318/CEE relativa a la aproximación de las legislaciones de los Estados miembros sobre Normas y Protocolos analíticos, toxicofarmacológicos y clínicos en materia de pruebas de especialidades farmacéuticas, DO número L15, 31-33,17.1.87.
  • EEC: Directiva del Consejo 87/20/CEE por la que se modifica la Directiva 81/852/CEE relativa a la aproximación de las Legislaciones de los Estados miembros sobre las Normas y Protocolos analíticos, toxicofarmacológicos y clínicos en materia de pruebas de medicamentos veternarios, DO número L15,34-35,17.1.87.
  • EEC: Council Directive 88/320/EEC on the inspection and verification of the organizational processes and conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing of Chemicals (Good Laboratory Practice), OJECL 145,11.6.88.
  • EPA (US): Toxic Substances Control; Good Laboratory Practice Standards; Final Rule, FRA8, (230), 53921-53944, 1983a.
  • EPA: Pesticide Programs; Good Laboratory Practice Standards; Final Rule, FR4S, (230), 53945-53969, 1983b.
  • FDA (US): Non-clinical Laboratory Studies. Proposed regulations for Good Laboratory Practice, /7741, (225), 51206-51230,1976.
  • FDA: Non Clinical Laboratory Studies. Good Laboratory Practice Regulations, Final Rules, FR43, (247), 59986-60020, 1978.
  • MENENDEZ, M.: La legislación de las Comunidades económicas europeas sobre el uso de sustancias químicas. Rev. de Toxicología, 1 (1), 3-23,1984.
  • MOHW (Japón): Good Laboratory Practice Standards for Safety Studies on Drug, Notification313, Pharmaceuticall Affairs Bureau, 1982.
  • NEWZELAND: Testing Laboratory Registration Act1972,36,1972.
  • OECD: Decisión of the Council Concerning the special Programme on the Control of Chemicals, C (78), 127 (Final), París, 1978.
  • OECD: Special Programme on the control of Chemicals. Management Committee. Final report of the expert group on Good Laboratory Practice, ENV/CHEM/MC/8114, 1981.
  • OECD: Decission of the Council Concerning the Mutual Acceptance of Data in the Assesment of Chemicals, c (81) 30 (Final), 1981.
  • REPETTO, M.: Determinación experimental de la toxicidad. Rev. de Toxicología, 1 (2), 77-96, 1984.
  • REPETTO, M.: Estado actual de la Normativa Comunitaria sobre la clasificación de las sustancias químicas, Rev. Toxicología, 4 (2-3), 175-186, 1987.
  • SACRISTÁN, A.M.; FAU de CASAJUANA, R.; GÓMEZ, N. y BIRNIE, J.: Implementation of GLP and otherrelevant regulations in Spain, Proceedings of the Sixth Intemational Congress on Good Laboratory Practice. Stratford-upon Avon, UK, 1988.
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