GLP Exam Review 2023

GLP Exam Review 2023 FDA - food and drug adminstration EPA - environmental protection agency OECD - organization for economic cooperation and development CFR - code of federal regulation GMP - good manufacturing practice GCP - good clinical practice SOP - standard operating procedure NDA - new drug application QAU - quality assurance unit GLP regulations apply to phase I, II, III clinical trials - FALSE Extensive scientific fraud at industrial bio-test laboratories triggered the early formulation of GLP regulations - TRUE FDA inspections are unannounced - TRUE The testing of herbicides falls under the authority of the FDA - FALSE Several laboratories at Rush are GLP certified - FALSE GLP regulations need to be followed in basic R&D research - FALSE Raw data like original observations may be transcribed in a notebook the following day - FALSE You should review, sign, date your resume or curriculum vitae which will be part of your personnel and training records on an annual basis - TRUE SOPs are used to standardize routine repeated laboratory procedures - TRUE Experiments planned in protocol will supercede experimental procedures that already exist in a SOP - TRUE Laboratory notebooks must be filled out in permanent ink - TRUE An unplanned change in a SOP is called a_________ - deviation A planned change in a SOP is called an __________ - amendment The study initiation date is when _________ - the study director signs the protocol Under FDA GLP definitions a chemical being investigated as a potential new drug will be called a _____ in a study. - test article The location where the study director residues is called the test ______ - facility According to FDA GLP nomenclature the material derived from a test system for study or analysis is called a ____ - specimen the _____ of a study approves a study and usually provides financial support for the study - Sponsor Under FDA GLP regulations who has responsibility to determine the strength, purity and stability of materials to be tested? - management Who establishes the QAU for the study? - management The _____ has overall responsibility for the technical conduct of the study - study director GLP regulations often include the word 'shall'. in these regulations the word shall means which of the following (may, might, must) - Must An important part of GLP regulations include documentation of routine equipment maintenance and calibration verifications. how often should the following be checked? Repeating micropipets ______. balances _________ - monthly, per day of use If you transcribe data into your lab notebook, what must be done with the original data? - it must be saved and the transcribed data must be noted where to find original data How should you treat errors in your notebook - cross it out with one line so it can still be read and annotate it. initial and date and write a footnote explaining it most common problem encountered with notebooks as seen during quality assurance incorporated audits - legibility how are data sheets or SOPs on other paper be added to the notebook? - cut and taped into notebook neatly what is the minimum info required on the labels for a reagent solution bottle in the lab? - Continues...