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Good Laboratory Practices (GLPs)

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Until the mid 1970's the Food and Drug Administration (FDA) ... Two submissions aroused suspicion and resulted in 'for cause' inspections of sponsor laboratory ... – PowerPoint PPT presentation

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Title: Good Laboratory Practices (GLPs)


1
Good Laboratory Practices (GLPs)
  • Created by
  • Marc S. Hulin, DVM, Dipl. ACLAM

2
History
  • Until the mid 1970s 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

3
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

4
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

5
History
  • FDAs responsibility and authority for GLPs is
    derived from the Federal Food, Drug, and Cosmetic
    Act of 1985.

6
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

7
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

8
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

9
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

10
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

11
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

12
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)

13
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

14
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

15
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
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