good laboratory practices (glps) created by marc s. hulin, dvm, dipl. aclam
Post on 25-Dec-2015
212 Views
Preview:
TRANSCRIPT
Good Laboratory Practices(GLPs)
Created by
Marc S. Hulin, DVM, Dipl. ACLAM
History Until the mid 1970’s the Food and Drug
Administration (FDA) assumed that reports being submitted in support of new drug or medical device applications were accurate and truthful
Two submissions aroused suspicion and resulted in “for cause” inspections of sponsor laboratory
History “For cause” means an inspection initiated by FDA
when there is reason to suspect a problem in a regulated product.
Results presented to Congress:• experiments poorly conceived, executed or
inaccurately analyzed• technical personnel unaware of importance of
SOPs, accurate record keeping, observations, and compound administration
History• Management did not assure critical review of data
or proper personnel supervision• Scientific qualification and adequate personnel
training were lacking• Disregard for need to observe proper lab, animal
care, and data mngmt. Procedures• Sponsors failed to monitor contract testing labs• Failure to verify accuracy and completeness of
scientific data
History FDA’s responsibility and authority for
GLPs is derived from the Federal Food, Drug, and Cosmetic Act of 1985.
GLP Coverage Purpose of GLPs: assure the quality &
integrity of data submitted to FDA in support of the safety of regulated products
GLPs have heavy emphasis on data recording, record & specimen retention
Requires each study to have a study director Study director: ultimate responsibility for
implementation of the protocol & conduct of the study
GLP Coverage Covers all nonclinical laboratory studies Food & color additive petitions, NDA &
NADA Toxicity studies (in vitro & in vivo) Excluded: human subject trials, clinical
or field trials in animals, basic exploratory studies
Definitions Sponsor: person who initiates & supports
nonclinical laboratory study, a person who submits nonclinical study to FDA or testing facility that initiates & conducts the study
Testing facility: person who actually conducts a nonclinical laboratory study
Test system: any animal, plant, or microorganism to which test or control article is administered
Definitions Specimen: any material derived from a test
system for examination or analysis Raw data: any laboratory work sheets,
records, memoranda, notes or copies that are result of original observations
Quality assurance unit: monitor study conduct Study director: individual responsible for the
overall conduct of a nonclinical laboratory study
Quality Assurance Unit (QAU) QAU records are exempt from routine
FDA inspections Maintain a copy of master schedule
sheet of all nonclinical laboratory studies
Inspect each study at intervals adequate to assure the integrity of the study
Quality Assurance Unit (QAU) Determine that no deviations from
approved protocols or SOPs were made without proper authorization & documentation
Review the final study report to assure methods & SOPs reflect raw data
Maintenance & Calibration of Equipment
Equipment shall be adequately inspected, cleaned & maintained
Equipment used for assessment of data shall be tested, calibrated and/or standardized
Scales & balances should be calibrated at regular intervals (usually ranging from 1-12 months)
Standard Operating Procedures(SOPs)
Testing facility shall have SOPs adequate to insure the quality & integrity of the data generated in the course of a study
all deviations from SOPs shall be authorized by the study director & documented in the raw data
Animal Care SOPs are required for all aspects of
animal care Newly received animals shall be
isolated & health status evaluated Animals shall be free of any disease or
condition that might interfere at beginning of study
Animal Care Animals of different species shall be
housed in separate rooms Feed & water analyzed periodically for
contaminants Contaminant analysis of food & water
for each & every study is not a requirement nor is analysis for laundry list of contaminants
top related