Ensuring the Highest Level of Quality Standards
Quality Control and Quality Assurance form the foundation of UC Davis’ Gene Therapy Center and the Institute for Regenerative Cures. The center’s team members are experienced and skilled in every aspect of the QC/QA process. Standard operating procedures form the operational foundation for the Good Manufacturing Practice facility. The lab’s Quality Control group is responsible for ensuring quality at every level of manufacturing and overseeing product-release testing. The Quality Assurance team is the final authority for guaranteeing that tests and manufacturing processes are performed to prescribed specifications. Standard operating procedures are in place for all release tests, and all tests are controlled as specified. Certificates of Analysis are generated for final products, and the Quality Assurance group is responsible for the release of that product. Only when all certificates are in place and the release criteria are met can products be released. The lab also offers Sysmex instrumentation for progenitor cell enumeration (for clinical transplantation and cord blood banking units).
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