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