GLP Exam Definations 2023 Update Review

GLP Exam Definations 2023 Update Review FIFO - ANS-FIRST IN FIRST OUT - has to do with animals - feed, bedding, other lab supplies NIST - ANS-NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY QAI - ANS-QUALITY ASSURANCE INVESTIGATION QAU - ANS-QUALITY ASSURANCE UNIT - has to do with oversight - monitors each study - way for management to assure itself and other regulatory agencies that study was done according to GLPs - separate and independent from personnel engaged in conduct of study - review final reports then prepare and sign a statement to be included in final report - need SOPs (procedures) CFR - ANS-CODE FOR REGULATION AAALAC - ANS-ASSOCIATION FOR ASSESSMENT AND ACCREDITATION OF LABORATORY ANIMAL CARE IND - ANS-INVESTIGATIONAL NEW DRUG APPLICATION NDA - ANS-NEW DRUG APPLICATION glps - ANS-good scientific practices IBT - ANS-INDUSTRY BIO-TEST LABORATORY - triggered GLP regulations because of scandal FDA - ANS-FOOD AND DRUG ADMINISTRATION - does not accredit facilities for GLP compliance EPA - ANS-ENVIRONMENTAL PROTECTION AGENCY - does not accredit facilities for GLP compliance OECD - ANS-ORGANIZATION FOR ECONOMIC AND COOPERATION DEVELOPMENT - international GLP MAD - ANS-MUTAL ACCEPTANCE OF DATA - international GLP GMPS - ANS-GOOD MANUFACTURER PRACTICE STANDARDS GCPS - ANS-GOOD CLINICAL PRACTICE STANDARDS - provides protection of human subjects - assures credibility of trial data - ensures existence of essential documents ICH - ANS-INTERNATIONAL CONFERENCE ON HARMONIZATION - current thinking by the FDA FIFRA - ANS-FEDERAL INSECTICIDE FUNGICIDE AND RODENTCIDE ACT TSCA - ANS-TOXIC SUBSTANCE CONTROL ACT FORM 482 - ANS-NOTICE OF LAB INSPECTION (FDA) - typically no notice - this is given to management at opening conference - need to tell purpose and length of inspection - laboratory establishes ground rules CAPA - ANS-CORRECTIVE ACTION PREVENTIVE ACTION - even though you fixed the deviation from the SOP, how do you know it won't happen again FORM 483 - ANS-NOTICE OF LAB INSPECTION FINDINGS (FDA) - an opinion with no engagement of agency EIR - ANS-ESTABLISHMENT INSPECTION REPORT - takes lab response (w/n 15 days) under consideration and now its an agency determination BIMO - ANS-BIO-RESEARCH MONITORING - where the report and findings have been reviewed from 483 FOI - ANS-FREEDOM OF INFORMATION CDER - ANS-CENTER FOR DRUG EVALUATION AND RESEARCH (FDA) CBER - ANS-CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (FDA) CDRH - ANS-CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (FDA) CVM - ANS-CENTER FOR VETERINARY MEDICINE (FDA) CFSAN - ANS-CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (FDA) NCTR - ANS-NATIONAL CENTER FOR TOXICOLOGY RESEARCH (FDA) ORA - ANS-OFFICE OF REGULATORY AFFAIRS (FDA) IRB - ANS-INSTITUTIONAL REVIEW BOARD MTD - ANS-MAXIMUM TOLERABLE DOSE CRA - ANS-CLINICAL RESEARCH ASSOCIATE CRO - ANS-CONTRACT RESEARCH ORGANIZATION - contracted by sponsor to run study SOP - ANS-STANDARD OPERATING PROCEDURE - required for all equipment used on GLP studies - addresses methods/materials/schedules for cleaning, maintenance, testing, inspection, etc. - needs management approval - should be one for each routine, repetitive task - can't override GLP requirement AAALAC - ANS-ASSOCIATION FOR ASSESSMENT AND ACCREDITATION OF LABORATORY ANIMAL CARE LHQA - ANS-LIQUID HANDLING QUALITY ASSURANCE CofA - ANS-CERTIFICATE OF ANALYSIS - in characterization of TC articles, this should state GLP compliance USP - ANS-UNITED STATES PHARMACOPIA SPONSOR - ANS-- PERSON WHO INITIATES AND SUPPORTS A STUDY( FINANCIALLY OR BY OTHER RESOURCES) - person responsible for submitting to FDA after study finishes - A TESTING FACILITY. - they approve of the study, not the study director PERSON - ANS-INCLUDES AN INDIVIDUAL, PARTNERSHIP, CORP., ASSOCIATION, ACADEMIC ESTABLISHMENT, GOV AGENCY, OR LEGAL ENTITY STUDY DIRECTOR - ANS-INDIVIDUAL RESPONSIBLE FOR OVERALL TECHNICAL CONDUCT OF A NON CLINICAL STUDY - both OECD and FDA use this definition - need a single one of these at any point in time - responsibilities: conduct of study, interpretation, analysis, documentation, and reporting of results PRINCIPAL INVESTIGATOR - ANS-IN A MULTI-STUDY SITE THIS INDIVIDUAL ACTS ON BEHALF OF THE STUDY DIRECTOR - not defined by FDA but they agree QUALITY ASSURANCE UNIT - ANS-A PERSON OR ORGANIZATIONAL ELEMENT(EXCLUDING THE STUDY DIRECTOR) WHO MANAGES THE QUALITY ASSURANCE DUTIES IN A NON-CLINCAL STUDY TEST ARTICLE/ITEM - ANS-item: ANY OBJECT THAT IS THE SUBJECT OF THE STUDY (OECD) article: FDA definition...any additive for human use WHAT IS THE GLP MOTTO? - ANS-IF IT ISN'T WRITTEN DOWN OR E-RECORDED IT NEVER HAPPENED CONTROL ARTICLE/REFERENCE ITEM - ANS-ANY OBJECT USED IN THE STUDY TO PROVIDE A BASIS FOR COMPARISON WITH THE TEST ITEM/ARTICLE - FDA/OECD WHAT IS TREATED WITH TEST OR CONTROL ARTICLES? - ANS-TEST SYSTEM - OECD def: any biological, chemical, or physical system or a combo of them STUDY INITIATION DATE - ANS-DATE THE PROTOCOL IS SIGNED BY THE STUDY DIRECTOR STUDY COMPLETION DATE - ANS-DATE FINAL REPORT IS SIGNED BY THE STUDY DIRECTOR NON-CLINICAL LAB STUDY - ANS-IN VIVO OR IN VITRO EXPERIMENTS THAT ARE TESTED PROSPECTIVELY IN A TEST SYSTEM PROTOCOL - ANS-THE DOCUMENT THAT DEFINES THE OBJECTIVE AND EXPERIMENTAL DESIGN OF THE STUDY BEING DONE AND INCLUDES ANY AMENDMENTS - needs descriptive title and purpose of study, objectives of the study, and ALL methods, experimental design (including methods for controlling bias) - also needs date of approval by sponsor and the dated signature (initiation date) of study director STUDY PROTOCOL AMENDMENT - ANS-ANY [intended] CHANGE MADE TO THE STUDY PROTOCOL AFTER THE INITIATION DATE - become effective: by written or verbal approval by the study director STUDY PROTOCOL DEVIATION - ANS-UNINTENDED OR UNPLANNED DEPARTURE FROM THE PROTOCOL (doc that defines objective and expt design of study being done, including amendments) AFTER INITIATION DATE TESTING FACILITY - ANS-PERSONS OR LOCATION WHO ACTUALLY CONDUCTS THE NONCLINICAL LABORATORY STUDY; WHERE THE STUDY DIRECTOR IS LOCATED - actually using test article in a test system - management here is responsible with designating a study director (or PI) before study initiation - if replacing either...need to document it cGMP - ANS-CURRENT GOOD MANUFACTURING PRACTICES PAI - ANS-PRE-APPROVAL INSPECTION NOW - ANS-NOTICE OF WARNING...given by FDA HPLC - ANS-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY LCMS - ANS-LIQUID CHROMATOGRAPHY MASS SPECTROMETRY CAS - ANS-CHEMICAL ABSTRACT SERVICE TCR - ANS-TEST CONTROL AND REFERENCE - TC articles - article other than TA that is also given to test system - TCR articles - stability of these shall be determined prior to use in a study or at the same time as a study according to an SOP PI - ANS-PRINCIPLE INVESTIGATOR FFDCA - ANS-FEDERAL FOOD, DRUG, & COSMETIC ACT IDE - ANS-INVESTIGATIONAL DEVICE EXEMPTION WL - ANS-WRONG LOCATION WO - ANS-WRITE OVER SE - ANS-SPELLING ERROR CE - ANS-CALCULATION ERROR RE - ANS-RECORDING ERROR EE - ANS-ENTRY ERROR TEST SITE - ANS-LOCATION(S) AT WHICH THE PHASE(S) OF A STUDY ARE BEING CONDUCTED BATCH - ANS-A SPECIFIC QUANTITY OR LOT OF A TEST OR CONTROL ARTICLE/ITEM VEHICLE - ANS-ANY AGENT THAT SERVES AS A CARRIER USED TO MIX, DISPERSE, OR SOLUBILIZE THE TEST OR REFERENCE ITEM TO FACILITATE THE TEST SYSTEM - how you're delivering test article to system RAW DATA - ANS-ANY LAB WKST OR RECORD OF THE ORIGINAL OBSERVATIONS AND ACTIVITIES IN THE EXPERIMENT BEING CONDUCTED - includes: sticky notes, paper towels, napkins SPECIMEN - ANS-ANY MATERIAL DERIVED FROM A TEST SYSTEM FOR EXAMINATION OR ANALYSIS - GLP & GCP term...sample is interchangeable with it though inspection closure - ANS-- what you want to be the outcome of a FDA inspection (no findings) notice of warning letter - ANS-- what you don't want to be the outcome of a FDA inspection (FDA no longer accepts data from lab if they don't fix things inspector listed) phase 1 clinicals - ANS-- first trials in human subjects phase 2 clinicals - ANS-- determines efficacy - better defines dose and exposure related activity and toxicity phase 3 clinicals - ANS-- addtl. evidence of effectiveness - to better understand the adverse effects of drug phase 4 clinicals - ANS-- studies performed after drug is approved for marketing...involves pharmacovigilence (concerned about adverse effects) - its for studying a population that wasn't previously studied person (FDA) - ANS-- legal entities - not defined by OECD management of testing facility - ANS-- responsible with establishing study director and/or PI (and replacing them) - establishing QAU - checking test and control articles - authorize SOPs personnel - ANS-- need to be educated, trained, and have experience - needs to be adequate # of qualified ones to conduct study according to the protocol GLP compliance statement - ANS-- legal statement for enforcement action by FDA - what the study director has to sign and date at the same time as the final report GLP master schedule - ANS-- paper/electronic system identifying all GLP studies in the facility - FDA use: - evaluate work load at facility being audited - eval. work load on spec. study directors or PIs - select studies for review during FDA audit - maintained by QAU