VJ-GLP SLIDES - Presentation (61 slides)

VJ-GLP SLIDES - Presentation (61 slides) - GLP...

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(GOOD LABORATORY PRACTICES) GLP
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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 A 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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> 10,000 studies for EPA and FDA Experiments poorly conceived Experiments poorly executed Experiments inaccurately analyzed and reported FDA INVESTIGATIONAL FINDINGS
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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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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 FDA INVESTIGATIONAL FINDINGS
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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 FDA INVESTIGATIONAL FINDINGS
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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 FDA INVESTIGATIONAL FINDINGS
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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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What is OECD OECD stands for “Organization for Economic Cooperation and Development” A forum in which governments work together to address the economic, social and environmental challenges of interdependence and globalization Center for policy research Provider of instruments for harmonization, cooperation, cost sharing and outreach (transfer of technical expertise, policy experience, MAD) a “Club” OF 30 industrialized countries
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Objectives of OECD Assist member countries in identifying, preventing and reducing the risks of chemicals Promote sustainable development concerning activities related to chemicals within OECD and non- OECD countries Prevent un-necessary distortions in trade
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VJ-GLP SLIDES - Presentation (61 slides) - GLP...

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