The document discusses Good Laboratory Practice (GLP), established in the 1970s as a framework for conducting non-clinical laboratory studies to ensure safety data for humans and the environment. It highlights the importance of resources, protocols, quality assurance, and responsibilities involved in the research process, which typically spans approximately 12 years. GLP regulations aim to prevent fraud, ensure reproducibility, and streamline data management and reporting.

1. Presenters:
_Pramod Chaudhary
_Bipin Singh
_Surendra K. Bohara

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).

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

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.