Good Laboratory Practices (GLP) Exam 2023

Good Laboratory Practices (GLP) Exam 2023 Scope of GLPs - ANS-GLPs prescribe good laboratory practices for conducting *NONCLINICAL laboratory studies* that support applications for research/marketing permits for FDA-regulated products What products do GLP apply to? - ANS--food, animal and color additives -human and animal drugs -devices -biological and electronic products What do GLPs NOT cover? - ANS--human subjects -basic exploratory research What is the intent of the GLPs? - ANS--to assure the *quality and integrity* of data submitted to FDA -to allow for the *accurate reconstruction* of studies Impetus for GLP regulations? - ANS-IBT debacle (early 1970s) -need to assure data quality, as well as secure command and control -an audit trail was needed GLP is not to be confused with normal good practices in a lab - ANS--GLP does NOT assure "good science" -it DOES require than you create a sound plan; a detailed and pre-approved protocol -you need to *document that you followed your plan* 4 key aspects of GLP (IMPORTANT) - ANS--chain of command -a study plan -documentation -independent verification Chain of Command -main requirement? - ANS-The chain of command must include a single point of study control: the Study Director GLP Triumverate of control - ANS--management -study director -quality assurance unit Continues...