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This document discusses principles of Good Laboratory Practice (GLP). It provides background on GLP, including that it aims to ensure safety, consistency and quality in chemical and pharmaceutical non-clinical testing. GLP was first introduced in the 1970s and aims to prevent fraudulent lab practices. It outlines the Organization for Economic Co-operation and Development's role in harmonizing GLP standards internationally and describes the key aspects of GLP compliance, including facilities, equipment, test systems, documentation and personnel responsibilities.
assignment presentation ppt
- 1. NOIDA INSTITUTE OF ENGINEERING AND TECHNOLOGY (PHARMACY INSTITUTE) PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS (MPL-202T) TOPIC- Principles of Good Laboratory Practice(GLP) SUBMITED TO SUBMITED BY- Dr. SAUMYA DAS SHIVAM YADAV M.PHARM (PHARMACOLOGY SEM-2)
- 2. CONTENT • Good Laboratory Practice(GLP) • THINGS ON WHICH GLP APPLIED • PRINCIPLE OF GLP • History • ORGANISATION OF ECONOMIC COOPERATION AND DEVELOPMENT(OECD) • GLP COMPLETE PROCEDURE AND PERSONNEL RESPONSIBILITIES
- 3. GOOD LABORATORY PRACTICES • In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) nonclinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
- 4. THINGS ON WHICH GLP APPLIED • GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including • pharmaceuticals) to man, animals and the environment. • laboratory safety - appropriate gloves, glasses and clothing • to handle lab materials safely.
- 5. PRINCIPLE OF GLP • The principles of GLP aim to ensure and promote safety, consistency, high quality, and reliability of chemicals in the process of non- clinical and laboratory testing. GLP is not limited to chemicals and also applies to medical devices, food additives, food packaging, color additives and other non- pharmaceutical products or ingredients.
- 6. HISTORY • GLP was first introduced in New Zealand and Denmark in 1972. GLP was instituted in US following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. Industrial Bio Test Labs (IBT) was the most notable case, where thousands of safety tests for chemical manufacturers were falsely claimed to have been performed or were so poor that police investigators could not piece together what work had been done even though IBT superficially delivered the test results their contracts with the manufacturers specified.
- 7. • These issues were made public in the hearings at the US Congress, which led to the FDA's publication of Proposed Regulations on GLP in 1976, with establishment of the Final Rule in June 1979 (21 CFR 58). The Environmental Protection Agency (EPA) had also encountered similar problems in data submitted to it, and issued its own draft GLP regulations in 1979 and 1980, publishing the Final Rules in two separate parts (40 CFR 160 and 40 CFR 792) in 1983
- 8. ORGANISATION OF ECONOMIC COOPERATION AND DEVELOPMENT Following Decision C(97),186/Final of the OECD Council, data generated in the testing of chemicals in one OECD Member Country, in accordance with OECD Test Guidelines and the Principles of GLP are accepted in all other OECD Member Countries. OECD: ENV/MC/CHEM(98)17 part two GLP is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
- 9. GLP COMPLETE PROCEDURE AND PERSONNEL RESPONSIBILITES 1. Organization and Personnel • Management-Responsibilities • Sponsor-Responsibilities • Study Director-Responsibilities • Principal Investigator-Responsibilities • Study Personnel-Responsibilities
- 10. 2. Quality assurance program • Quality Assurance Personnel 3. Facilities • Test System Facilities • Facilities for Test and Reference Items 4. Equipment, reagents and materials 5. Test systems • Physical/Chemical • Biological
- 11. 6. Test and reference items 7. Standard operating procedures 8.Performance study • Study Plan • Conduct of Study 9. Reporting of result 10.Archival - Storage of Records and Reports OECD Guidelines for the Testing of Chemicals .
- 12. OECD Guidelines for the Testing of Chemicals • OECD publishes OECD Guidelines for the Testing of Chemicals, which are guidelines that usually have to be followed for GLP compliance. They are widely required by agencies doing risk assessments of chemicals
- 13. THANK YOU