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Approval to Conduct GLP Studies
Organizational units (departments or laboratories) desiring
to conduct or provide services for GLP studies must be approved in advance by
the ORC. When requests are received a
representative from the ORC’s Quality Assurance Unit (QAU) will meet with the
investigator and management to determine the nature and scope of the GLP
project. If management approves the project, a formal GLP inspection will be
conducted by the QAU. The QAU will issue a written inspection report and meet
with the investigator and management to review findings from the inspection.
The ORC will issue a written statement of compliance when a department and/or
laboratory satisfy the GLP requirements. The QAU will recommend corrective actions,
propose a timeline, and schedule a re-inspection if the department or
laboratory does not satisfy GLP requirements.
The QAU will perform quality system inspections at least biennially to monitor GLP compliance of all Texas A&M facilities approved to participate in GLP studies.