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Quality System Program
Purpose
The Texas A&M University, College Station (Texas A&M) Quality System Program (QSP) establishes the guidelines and basic procedures that must be followed to ensure the quality and integrity of nonclinical laboratory studies that support or are intended to support applications for research and marketing permits as defined in the Food and Drug Administration (FDA), 21 CFR, Part 58, Good Laboratory Practices for Nonclinical Laboratory Studies (GLP).
Scope
The Quality System Program applies to all Texas A&M facilities that desire to participate in nonclinical laboratory studies as defined in the FDA GLP regulations. Each department or laboratory participating in GLP studies must comply with the GLP regulations and Texas A&M QSP to the extent of the services they provide.
Detailed Information on the QSP
Quality System Program Oversight
Approval to Conduct GLP Studies
Assistance with Quality System Implementation
Reagents and Solutions / Expired Supplies and Materials
- Test and Control Article Characterization (Receipt, storage, mixing, characterization, reserve samples, documentation)
- Mixtures of Test and Control Articles
- Test and Control Article Storage
- Reserve Samples of Test and Control Articles
Study Protocol and Study Conduct
Data Collection, Data Management and Document Control