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

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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

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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

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History

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

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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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