Transcript Good Laboratory Practices (GLPs)

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