Process inspections and the OECD GLP Principles
نویسندگان
چکیده
منابع مشابه
OECD 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...
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For the implementation of the Organisation for Economic Co-operation and Development (OEC D) principles of good laboratory practice (GLP) and performance of studies according to worldwide regulatory requirements, test facilities (TFs) in Japan have been making constant effort to promote better understanding of this matter and improve communication with monitoring authorities (MAs). Their activi...
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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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The Organisation for Economic Cooperation and Development (OEC D) principles of good laboratory practice (GLP) were originally developed for application to animal-based toxicology studies. On the other hand, more and more studies involving in vitro test systems are performed to produce data on the safety of chemicals with respect to human health and the environment. Therefore, national legislat...
متن کاملFuture issues including broadening the scope of the GLP principles.
When the principles of good laboratory practice (GLP) were drafted in 1982 by the Organisation for Economic Cooperation and Development (OECD) the electronic era was in its infant stages and many of the issues surrounding what may affect the environment and human health was not expected. Today, advances in technology for capturing and recording data for the reconstruction of a study are availab...
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ژورنال
عنوان ژورنال: The Quality Assurance Journal
سال: 2007
ISSN: 1087-8378,1099-1786
DOI: 10.1002/qaj.417