Quality Assurance Unit
The Quality Assurance Unit monitors and oversees all good manufacturing practice and quality-control activities in the Gene and Virus Therapy Shared Resource.
The unit includes a quality assurance officer who is independent of the operations of the Viral Vector Production Laboratory and the Viral Toxicology Pharmacology Laboratory. This quality assurance officer:
- Determines if a clinical product manufactured by the shared resource meets the release specifications for clinical use
- Audits preclinical toxicology and pharmacology studies