schedule l1 glp pdf

Head of the laboratory must be of high professional standing with experience in drug analysis and laboratory c. Close suggestions Search Search. The test facility should have a sufficient number of rooms or areas to assure the isolation of test systems and the isolation of individual projects, involving substances or organisms known to be or suspected of being bio hazardous. Good Laboratory Practices GLPs are standard regulatory programs that assure the quality and integrity of nonclinical safety test data submitted to regulatory agencies worldwide. Management review: Quality system reviews shall be conducted by the top management atleast once in every twelve months and the agenda of review shall generally cover the following:- i report or input of internal audits; ii matter arising from previous reviews iii report of external audits, if any; iv surveillance report, if any; v result of proficiency testing complaints or feedback received from users of laboratory vi services; vii details of in-house quality control checks; viii need of amendment of the quality system and documentation ix induction training of new staff; and x any other requirements of the laboratory

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