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.