[OECD series on principles of good laboratory practice and compliance monitoring].
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منابع مشابه
Quest for harmonisation: differences and similarities in national programmes for GLP monitoring. A senior inspector's viewpoint.
The conditions under which safety data may be accepted by regulatory authorities (RAs) in OECD Countries do not only include the obligation to apply the principles of good laboratory practice (GLP) while producing these data, but also must countries, partaking in the Organisation for Economic Cooperation and Development (OECD) system for mutual acceptance of data (MAD), establish a monitoring p...
متن کاملImplementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard.
Laboratories with a quality system accredited to the ISO/IEC 17025 standard have a definite advantage, compared to non-accredited laboratories, when preparing their facilities for the implementation of the principles of good laboratory practice (GLP) of the Organisation for Economic Co-operation and Development (OECD). Accredited laboratories have an established quality system covering the admi...
متن کاملOECD and USA GLP applications.
Since the inception of the FDA good laboratory practice (GLP) regulations in 1979, the Organisation for Economic Co-operation and Development (OECD) principles of GLP in 1981 and the finalization of the EPA GLP programme in 1983 there have been recognizable differences among the three compliance programmes. All have been revised since their initial publication, but still there remain difference...
متن کاملGood laboratory practice in the European Community. Role of the commission and the member states: external aspects.
The paper recalls the history of the development of the OECD principles of good laboratory practice (GLP) and explains why the European Community has a role to play in the area of GLP. It presents briefly the current legal framework in the European Community (Directives 87/18/EEC and 88/320/EEC) and describes the role of the Commission and the member states in the practical implementation of th...
متن کاملOECD principles of GLP: what is working and what needs work.
The Organisation for Economic Co-operation and Development (OECD) principles of good laboratory practice (GLP) are intended to assure data quality and integrity. The pre-clinical safety data generated in an OECD member country in accordance with the principles of GLP are indeed accepted in other member countries for purposes of assessment. Regulatory authorities (RA) routinely further assess su...
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عنوان ژورنال:
- Annali dell'Istituto superiore di sanita
دوره 33 1 شماره
صفحات -
تاریخ انتشار 1997