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Good Laboratory Practices Questions And Answers 2023

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Good Laboratory Practices Questions And Answers 2023 Why were GLP regulations developed? - ANS-To establish uniform guidelines Why do we have to follow GLP regulations? - ANS-When conducting non-clinical trials to establish the safety of: -food + color additives -drugs -medical devices -pesticides What is the Memorandum of Understanding btw FDA and Health Canada? - ANS-That drugs tested in CAN can be used in the USA and vice versa What does GLP regulate? - ANS-All the methods that must be used to conduct preclinical trials including documentation of data Why do we follow GLP regulations? - ANS-Assures the quality of the research How do we make sure that GLPs are being followed? - ANS-Indepedent unit from hte one conducting the study (called QA unit) What are the roles of QA? - ANS-1-Monitor the study to ensure compliance w/GLP regulations 2-Perform inspections to ensure compliance w/protocol and SOPs What is an SOP? - ANS-Standard Operating Procedure Why do we use SOPs? - Continues...

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