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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 BASED




Time 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.
Good Laboratory Practice

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Good Laboratory Practice

  • 2. > “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).
  • 3.
  • 4. RESEARCH CLINICAL NON-CLINICAL POST APPROVAL & DESCOVERY STUDY BASED PROCESS BASED Time line approximately 12yrs.
  • 5. >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
  • 6.
  • 7. >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.