GOOD LABORATORY PRACTICES history

Sakeena Asmi
MSc Biotechnology

1. HISTORY SAKEENA ASMI MAHATMA GANDHI UNIVERSITY

2. A quality system concerned with the organizational process and the conditions under which non clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

3. • GLP is to certify that every step of the analysis is valid or not. • Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products . • GLPs have heavy emphasis on data recording , record & specimen retention. PURPOSE OF GLP

4. Food and Drug Administration(FDA) 21 CFR part 58 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 .

5. Aside from the animal health and welfare issues , examples of scientific misconduct were also commonly seen at IBT . Fabrication of data. removal of health effect findings from reports. replacement of dead study animals with healthy ones that had not received drug treatment. changes in the interpretation of histopathology slides. changes in report conclusions to make them look more favorable were repeated occurrences.

6. G.D SEARLE & COMPANY(SERALE) Producer of pharmaceutical and food products like Aldactone , Aspartame and Flagyl . Suspicions about Searle’s data were aroused in 1972 while studies were being performed to gain approval for long-term use of the prescription drug Flagyl , which had already been approved for short-term use by the FDA. Aldactone caused cancer. Other misconducts: Lack of personnel training Deviations from study protocols Problems related to documentation Lack of quality control

7. Based on the findings of these inspections, the final GLP regulations were published on 22 December 1978 and became law on 20 June 1979. Proposed changes to the GLPs were published in 1984 , revisions were made, and Good Laboratory Practice Regulations, The Final Rule, were published on 4 September 1987.

8. Organisation for Economic Co-operation and Development(OECD) The OECD Principles of GLP were first developed by an Expert Group on GLP established in 1978 under the Special program on the Control of Chemicals . Principles of GLP were adopted by the OECD in 1981 . Expert Group was established in 1995 to develop a proposal to revise the Principles of GLP .

9. The Revised OECD Principles of GLP were reviewed in the relevant policy bodies of the Organisation and were adopted by Council on 26 November, 1997. Indian GLP Compliance Monitoring Authority - April, 2002.

10. THANK YOU