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Good Laboratory Practice
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Good Laboratory Practice

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This is presentation on behalf of the student's term paper presentation at Central institute for science and technology, Kathmandu

This is presentation on behalf of the student's term paper presentation at Central institute for science and technology, Kathmandu

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    Good Laboratory Practice Good Laboratory Practice Presentation Transcript

    • Presenters:_Pramod Chaudhary_Bipin Singh_Surendra K. Bohara
    • > “Good Laboratory practice” introduced in 1970s>Is a frame work for lab. Studies>Generate safety data>Applied on non-clinical studies>Safety to human/environment>Studies are submitted to NRA(National Registration Authority).
    • RESEARCH CLINICAL NON-CLINICAL POST APPROVAL&DESCOVERY STUDY BASED PROCESS BASEDTime line approximately 12yrs.
    • >Rsources: Human, Facilities, calibrated equipments>Characterizations: Study characters of materials>Rules: Protocols/study plans, written procedures>Results: Raw data, study reports, Achieves>Quality Assurance: acts as ‘WITNESS’ in research>Responsibilities: for sponsor management>Adequate lab. Space: avoid cross-contaminations
    • >Quality Assurance>Fraud>Reproductivity>GLP is a regulation>Traceries and integrate the data>Defines & stand arise: planning, performance, reporting, recordings, monitoring, archives.>Avoidance of repeated testing.