Introduction To Good Lab Practice
INTRODUCTION TO GOOD LAB PRACTICES (GLP) Good Lab Practices (GLP) specifically refers to quality system of management controls for research laboratories or organization to ensure the quality, reproducibility consistency, integrity of chemicals (including pharmaceuticals) nonclinical safety test. At the very first New Zealand and Denmark in 1972 introduced Good Lab Practices (GLP) and then later in 1978 it was introduced in USA in response to Industrial Biotest Scandal. Organizations for Economic Cooperation’s and Development (OECD) followed a years later for principals of GLP 1992, OECD helped to promulgate GLP in many countries. Set of principles have been embodied by GLP that provides frame work within which laboratory studies planned performed, …show more content…
The inspection of studies and test facilities revealed instances of inadequate planning and incompetent execution of studies, insufficient documentation of methods and results, and even cases of fraud. For example, replacing animals which had died during a study with new ones (which had not been treated appropriately with the test compound) without documenting this fact; taking hematology data for control animals from control groups not connected with the study; deleting gross necropsy observations because the histopathology’s received no specimens of these lesions; and retrospectively changing raw data in order to “fit the result tables” in the final report. These deficiencies were made public in the Kennedy-Hearings of the US Congress, and the political outcome of these hearings 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).Good Lab Practices (GLP) was first introduced in New Zealand and Denmark in 1972. Good Lab Practices was instituted in USA followed by cases of fraud generated by toxicology labs in data submitted by FDA by pharmaceutical companies. The Environment Protection Agency had also encountered similar problems in data submitted to It and issued its own draft for Good Lab Practices regulation in 1979 and 1980 (40 CFR 160 and 40 CFR 792)
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