Good Laboratory Practices 2023 Exam

Good Laboratory Practices 2023 Exam What CRF rule would apply? - ANS-21CRF Part 58 GLP - ANS-Good Laboratory Practice What do GLPs do? - ANS-ensure that a study can be reproduced in its entirety at a future time with similar results What must inspections require to report for reconstruction and evaluation? - ANSsecure storage of raw data, documentation, protocol, final reports, specimens and samples Why were GLP regulations developed? - ANS-to improve the trustworthiness of safety data on new drugs and chemicals submitted to US regulatory agencies (T/F) GLPs are not regulated and enforced by the FDA - ANS-False, they are. They are under authority of the FD&C and PHS act. Both acts ensure products that meet minimum safety and effectiveness standards. (T/F) Clinical laboratory study results help in deciding if a product is safe for first-inhuman clinical trials - ANS-False, it's nonclinical laboratory studies FIH - ANS-first in human FD&C Act - ANS-Federal Food, Drug and Cosmetic Act PHS Act - ANS-Public Health Service Act GLP Core Principles - ANS-- accuracy and reproducibility of lab studies - accurate and transparent reporting - thorough and legible documentation - accountability and secure long-term retention of records QAU - ANS-Quality Assurance Unit What does GLP require? - ANS-An independent quality assurance unit that monitors the study and ensures facility, equipment, personnel, methods, practices, records and controls conform with GLP regs (T/F) FDA refers to GLP studies and nonclinical studies - ANS-True GLP Key Elements - ANS-- facility where the study phases are conducted - SOPs - Personnel involved in the study - equipment -test articles being studied - biological system in which articles are tested - documentation of the study planning - final results - retention of records (T/F) All US & international GLP regs contain the same key elements that make up a GLP-complaint study - ANS-True What are the 3 personnel functions - ANS-testing facility management, study director and qau (T/F) GLPs are more specific on technology and instrumentation (due to rapid changes) - ANS-False, they are less specific What does subpart A - General Provisions consists of? - ANS-- Scope: describes types of products regulated by agencies - Definitions: covers items to be tested, controls, test system, specimen, batch, raw data, study start date and study end date - Inspection of a Testing Facility: testing facility responsibilities What does subpart B - Organization and Personnel consists of? - ANS-- personnel having appropriate education, experience & qualification - adequate # of study personnel, trained for their roles and responsibilities - trained in lab safety, GLP regs, SOPs, protocols and policies - personnel section emphasized maintaining each individuals training docs, cv, job description and training records Study Director responsibilities - ANS-- GLP study's technical conduct - results interpretation - analysis - documentation - reporting Study Director's Role - ANS-- approving protocol and amendments - assuring personnel follow protocol and regs - oversees data collection - study conduct - reporting - ensures excursions from protocol are documented (T/F) QAU participates in the study - ANS-False, they do not Are QAU trained in GLPs? - ANS-Yes PV - ANS-Protocol violation (T/F) QAU must be dependent on the study directior - ANS-False, independent of the study director & cannot report to the study director or other persons involved with the GLP study SD - ANS-Study director (T/F) QAU determines if PVs happen - ANS-True What does Subpart C consists of? - ANS-Facilities; they must be suitably constructed and of sufficient size to accommodate activities Animal care facilities - ANS-focuses on animal care Animal Supply Facilites - ANS-animal feeding, bedding, and housing Subpart D consists of - ANS-Equipment (design): analytical instruments and lab equipment for data collection (T/F) testing and calibration must be documented in an SOP - ANS-True Subpart E consists of... - ANS-Testing facilities operation with SOPs, reagents/solutions and animal care Subpart F consists of... - ANS-Test and control Articles which consist of T&CA characterization, test and control handing and mixtures of articles with carriers Subpart G consists of... - ANS-protocol for and conduct of a nonclinical laboratory study; each study has 1 protocol, a study director and a final report (T/F) Sponsor approves protocol - ANS-true (T/F) The study start date is when the sponsor approves the protocol - ANS-False; it begins when the study director signs the protocol Protocol deviation - ANS-any unplanned excursion from the protocol that is documented Subpart J consists of... - ANS-records and reports; reporting of nonclinical laboratory study results (study director signs final report which sets the study completion date) Part K consists of... - ANS-disqualification of a testing facility that includes 9 sections of reasons a lab may be disqualified and steps required for reinstatement (T/F) All labs operation within the US and internationally that perform GLP are subject to inspections - ANS-False, just within the US What are the 4 main reasons for inspections? - ANS-1. routine inspection...