VJ-GLP SLIDES (Revised 33 slides)

VJ-GLP SLIDES (Revised 33 slides) - GLP (GOOD LABORATORY...

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GLP (GOOD LABORATORY PRACTICES)
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What is GOOD LABORATORY PRACTICE (GLP) ? GLP IS A Quality System concerned with the Organizational process and the conditions under which non- clinical health and environmental safety studies are: - Planned - Performed - Monitored - Recorded - Reported - Archived
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Why GLP ? 1975 – US FDA doubted accuracy of some data 1976-78 FDA conducted pilot inspections of 98 laboratories in US 5 laboratories were subjected to regulatory proceedings of malpractice Few individuals were sent to Jail and fine Hence, FDA concluded a need to improve laboratory standards and a monitoring system
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FDA INVESTIGATIONAL FINDINGS > 10,000 studies for EPA and FDA Experiments poorly conceived Experiments poorly executed Experiments inaccurately analyzed and reported
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FDA INVESTIGATIONAL FINDINGS Technical personnel unaware of importance - Of protocol adherence - Of accurate observation - Of accurate administration of test substance - Of accurate record keeping - Of record transcription
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FDA INVESTIGATIONAL FINDINGS Technical personnel poorly trained and supervised Inadequate records for all operations Test system in poor health Animal ID not maintained Reported lab tests were not conducted Falsification of pathology reports
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FDA INVESTIGATIONAL FINDINGS Protocol design did not allow the evaluation of available data No assurance for scientific qualifications and adequate training of personnel Disregard for the need to observe proper lab, animal care, and data management procedures
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FDA INVESTIGATIONAL FINDINGS Last observations at necropsy not properly recorded Tumors observed at necropsy not examined histopathologically Reported animals were actually not examined Study data falsified Resurrection of dead animals
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FDA INVESTIGATIONAL FINDINGS Sponsors failed to monitor studies at contract labs Labs failed to verify accuracy and completeness of scientific data in final report
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GLP Around the World 1978 US FDA: GLP Regulations for non-clinical laboratory studies (FDA GLP) 1981 OECD: Council adopts the OECD Principles of GLP, recommends that member countries apply them to chemical testing (OECD GLP) 1982 Japanese MHW: Issued GLP standards for safety studies on drugs (JMHW GLP)
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This note was uploaded on 10/07/2010 for the course DBT 456 taught by Professor Ss during the Spring '10 term at Indian Institute of Technology, Guwahati.

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VJ-GLP SLIDES (Revised 33 slides) - GLP (GOOD LABORATORY...

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