elizabeth.pptxcgjfgugugitigiigjguihgiigig

DtJgdagfslhfsslrosorssfst

1. BY ELIZABETH.N.KANDJUMBI Good Laboratory Practices INDUSTRIAL PHARMACY

2. What is GLP? Definition: Good Laboratory Practice (GLP) refers to a set of principles intended to ensure the quality, reliability, integrity, and reproducibility of non-clinical laboratory studies. Purpose: To promote data integrity and traceability. To ensure safety and efficacy testing of drugs, chemicals, and cosmetics follows uniform standards. To facilitate regulatory acceptance by agencies such as OECD, USFDA, WHO, and CDSCO (India). Origin: Developed by the Organisation for Economic Co-operation and Development (OECD) in the 1970s. In India, GLP is governed by the National GLP Compliance Monitoring Authority (NGCMA) under the Department of Science and Technology (DST).

3. Key principles (OECD-Based): 1. Organization & Personnel: Clearly defined roles, trained staff, and accountability. 2. Facilities: Appropriate design for specific studies; separate areas for test and control. 3. Equipment: Properly maintained, calibrated, and validated instruments. 4. Test & Reference Items: Proper characterization, storage, and handling. 5. Standard Operating Procedures (SOPs): Written procedures for all tasks. 6. Study Plan & Performance: Pre-approved protocol, with adherence to methods. 7. Data Recording & Reporting: Real-time documentation; no falsification. 8. Archiving: Secure storage of raw data, specimens, and final reports. Principles of GLP

4. Regulatory Body: National GLP Compliance Monitoring Authority (NGCMA), established in 2002. India became OECD GLP Mutual Acceptance of Data (MAD) member in 2011 — so Indian GLP data is accepted by OECD countries. Process: Application to NGCMA. Facility inspection by GLP auditors. Compliance certificate issued (valid for 3 years). GLP-Certified Facilities in India: Includes contract research organizations (CROs), pharmaceutical R&D labs, and toxicology labs. GLP Certification in India

5. Ensures reproducibility, reliability, and credibility of laboratory data. Facilitates regulatory approvals for new drugs and chemicals. Promotes ethical, transparent, and standardized scientific practice. Reduces risk of data falsification or errors. Improves global acceptance of laboratory results in OECD countries. Importance & Benefits of GLP

6. GLP is a quality system that governs laboratory practices. It ensures accuracy, reliability, and integrity of non-clinical data. Certified GLP labs are globally recognized and critical in drug development and preclinical safety testing. Following GLP principles: Protects human and environmental safety. Ensures regulatory compliance. Supports international acceptance of research findings. Adherence to GLP is essential for pharmaceutical industries to maintain high standards of laboratory research and ensure patient and public safety. Summary

7. Thank you