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Testing Facility Management
Testing facility management is comprised of the Vice President of Research, Director of Research Compliance, deans, department heads, directors, managers, and supervisors. Each level of management is responsible for ensuring and maintaining GLP compliance for their respective organizational unit (refer to Texas A&M SOP for Testing Facility Management). Texas A&M testing facility management will:
- Assure there is a quality assurance unit that is providing quality assurance services for GLP studies.
- Designate a study director prior to the start of a study when Texas A&M is the primary testing facility (i.e., when the test or control articles are administered to the test system at Texas A&M).
- Replace the study director should it become necessary.
- Assure that personnel clearly understand the functions they are to perform.
- Assure facilities, resources, personnel, equipment, materials, and methodologies are available to meet GLP study requirements.
- Assure that test and control articles or mixtures are properly tested to determine their identity, strength, purity, stability, and uniformity (as applicable to the article or mixture).
- Assure that any deviations from the regulations, SOP, and study protocols are reported to the study director and that corrective actions are taken and documented.