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GLPs are very specific regulatory requirements for conducting the kinds of research listed below.

  1. Non-clinical laboratory studies that support or are meant to support applications for research, or marketing permits for products regulated by the FDA, including food and color additives, animal feed additives, human and animal drugs, medical devices for human use, biological products, and electronic products (21 CFR 58).
  2. Studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA (40 CFR 160).
  3. Studies relating to health effects, environmental effects, and chemical fate testing of chemicals that are regulated under the Toxic Substance Control Act, including but not limited to polychlorinated biphenyls, asbestos, radon and lead-based paints (40 CFR 792).

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GLPs ensure the quality and integrity of data and allow for the study to be reconstructed. The following are a few key components of GLP requirements. Please refer to the specific regulation for all of the requirements.

  • Personnel: Personnel engaged in a GLP study must have the appropriate education, training and experience, and their current resume, job description, and scientific and GLP training record must be maintained. All personnel engaged in a GLP study should also review and follow the protocol or Standard Operating Procedure (SOP).
  • Test Facility Management: The Test Facility Management designates a study director before initiating a GLP study and assures an independent Quality Assurance Unit (QAU) monitors the GLP study.
  • Study Director: The Study Director is the single point of study control responsible for the conduct of a GLP study. The Study Director ensures compliance with all GLP requirements.
  • Quality Assurance Unit: The Quality Assurance Unit is an independent unit that inspects a study at regular intervals to ensure management of the facilities, equipment, personnel, methods, practices, records and controls follows GLP requirements. The QAU maintains written records of each inspection, provides periodic status reports to management and the study director, and reviews the final report.
  • Facilities: The facilities used in a GLP study must be of suitable size and construction and designed for an adequate degree of separation to prevent any activity to have an adverse effect on the study.
  • Equipment: The equipment used to generate, measure or assess data in a GLP study must be of appropriate design, adequate capacity and be well-maintained and routinely calibrated.
  • Test Facility Operation: Test Facility Operation requires written SOPs that are accurate, current, approved, available, reviewed and followed for all routine procedures in a GLP study.
  • Protocol: The Protocol is a written plan of action that clearly indicates the objectives and all methods for the study. The sponsor and the study director must approve the protocol, and the study must be conducted in accordance with the protocol.
  • Records and Reports: Records and reports of all raw data, documentation, protocols, final reports, and specimens generated as a result of a GLP study must be retained for the time specified by GLP requirements.
  • Storing and Archiving: Storing and archiving for all records and reports for a GLP study must be done in a manner that minimizes deterioration and allows for the orderly storage and expedient retrieval of records and reports.
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