Good Laboratory Practice

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

1. G ood L aboraotry P ractice (GLP) Presenters: _Pramod Chaudhary _ Bipin Singh _Surendra K. Bohara

2. CONCEPT > “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. TRIAD CONCEPT.. MATERIAL SYSTEM HUMAN RESOURCE

4. DRUG LIFE CYCLE.. Time line approximately 12yrs . STAGE 1 STAGE 2 STAGE 3 STAGE 4 RESEARCH & DESCOVERY NON-CLINICAL CLINICAL POST APPROVAL GLP GCP GMP MANUFACTURING STUDY BASED PROCESS BASED

5. KEY REQUIREMENTS. >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. IMPORTANCE..

7. IMPORTANCE… >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.

8. THANK YOU