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Quality Assurance Unit (QAU)

SRI's QAU assures clients and management that for all projects conducted by SRI under GLP or cGMP regulations, the facilities, equipment, personnel, methods, practices, records and controls utilized during each study/project are in conformance with the applicable regulations.

For each project, the Quality Assurance Unit is entirely independent of the personnel engaged in the direction and conduct of production.

QAU Responsibilities

• Conduct GLP and cGMP training courses. Assure that each individual engaged in or supervising the conduct of a study/project has documentation of adequate training.
  
  
• Maintain a Master Schedule sheet listing all studies conducted at SRI under EPA, FDA, or other Good Laboratory Practice regulations.
  
  
• Assure that all aspects of a study/project necessary to maintain the integrity of that study/project are detailed by properly authorized standard operating procedures (SOPs) or in the project protocol.
  
  
• Review, distribute, and maintain all SOPs written for regulatory compliance.
  
  
• Perform audits of computer validation, protocols, raw data and reports.
  
  
• Inspect each project at intervals adequate to ensure the integrity of the project, and maintain written and properly reviewed records of these inspections.
  
  
• Periodically perform general inspections of SRI's GLP and GMP facilities, and maintain written and properly reviewed records of these inspections.
  
  
• Review the raw data generated during regulated study/project to assure that study/project procedures and experimental data were properly recorded and verified.
  
  
• Review final study reports to assure that each report accurately describes the methods and standard operating procedures utilized during the study, and that the reported results reflect the raw data of the study (GLP only).
  
  
• Prepare and sign a statement to be included with each final study report specifying the dates study inspections were made and findings reported to management and to the study director (GLP only).
  
  
• Review Master Production and Control Records.
  
  
• Review production and control records for each batch prior to releasing the batch for distribution.
  
  
• Review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.
  
  
• Approve or reject drug products manufactured, processed, packed, or held under contract by another company.
  
  
• Participate, as requested, in inspections of SRI facilities conducted by sponsors and potential sponsors of regulated projects and supervise inspections conducted by authorized regulatory agency representatives.

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     Last Updated Mar 19, 2009