GLP Certification Exam 2023

GLP Certification Exam 2023 IND - ANS-Investigational new drug( application) NDA - ANS-new drug application Motto - ANS-if it isn't written down it never happened t What triggered GLP regulations - ANS-IBT industrial bio-test lab. failed audit; sponsor failure to validate data/data not critically reviewed/ non-adherence to protocols/inaccurate analysis/untrained personnel use FFDCA - ANS-federal food drug and cosmetic act CFR - ANS-code of federal regulation -anything under FDA always volume 21 GCP - ANS-good clinical practice FIFRA - ANS-federal insecticide, fungicide, and rodenticide act TSCA - ANS-toxic substance control act most sold pesticide - ANS-herbicide "international" GLPs - ANS-OECD and MAD OECD - ANS-Organization for economic cooperation and development MAD - ANS-mutual acceptance data Goal of MAD - ANS-acceptance of data by all countries which subscribe to it -a country can accept MAD without being an OECD member EPA - ANS-environmental protection agency; under FIFRA Accreditation/Certification of Facilities conducting GLP studies - ANS-- not in US -in those international countries that prescribe to OECD/MAD, each individual country accredits labs for GLP work -only accredited for SPECIFIC study type FDA v. EPA Inspection - ANS-~2-3 years FDA- unannounced EPA- one week notice requested by scientific reviewers/cause inspections FDA GLP inspection purposes - ANS--compliance with GLP standards -consistency of Raw Data -retention of Raw Data -re-constructability of study -adherence to test guidelines -scientific soundness FDA inspection: opening conference - ANS--who should be present -issue 482 to management -purpose of inspection -length of inspection -lab establishes ground rules ***cannot make copies/walk around unaccompanied*** CAN TAKE PICTURES; you want exact copy FDA conducts GLP inspections through - ANS-1)review of : raw data, reports, records, correspondence in email ONLY TALK ABOUT ONE DRUG/STUDY AT A TIME avoid being reviewed for all 2)interviews 3)observations of facilities, equipment, and operations FDA inspections: closing conference - ANS-- who should be present -issue form 483 to management ( ALL FINDINGS) -overview of what was looked at/LIST OF DOCUMENTS TO BE TAKEN -inspector discusses individual findings listed on 483 483/exhibits taken used for audit report -lab can rebut findings *****15 days to respond in writing******* after what point will FDA no longer accept data from a lab? - ANS-after they receive a notice of warning letter Continues...