End-to-end, we NEVER sacrifice quality
QuVa uses only FDA-approved, commercially available sterile starting material to compound our sterile-to-sterile products.
From the moment we take delivery of commercially available sterile starting material, to the time our ready-to-administer products arrive at your hospital, we never sacrifice quality.
Our Manufacturing Process
At the time each item is received, it is reviewed against QuVa’s requirements, and the incoming Certificate Of Analysis (COA) or Certificate Of Conformity (COC)
The product barcode is scanned and added to our production system. The FDA-approved sterile drug components are transported to the prep area.
The components are prepped and decontaminated with approved and qualified cleaning agents before being moved into our ISO certified clean rooms. Sterile barriers and aseptic techniques safeguard against contamination.
We use both single use and reusable gowns and are actually moving to reusables more in light of the COVID crisis.
Drug compounding is carried out in an environmentally controlled and monitored environment by qualified QuVa professionals. Strict personnel and environmental monitoring is applied for each batch produced to ensure the environment is maintained at all times within the ISO 5 classified space. Monitoring results are recorded as part of our quality control testing reports and required for specific batch release.
Every compounded batch undergoes rigorous quality control testing. We use state-of-the-art technology including Ultra Performance Liquid Chromatography (UPLC) for Potency, BioMerieux Scan RDI for Sterility, and Charles River Endosafe for Endotoxin, as well as traditional methods.
Labeling & packaging
QuVa’s proprietary labels help to ensure against medication errors though increased readability, prominent beyond use expiry dates (BUD) and barcoding. QuVa’s labels are 100% compliant with the Drug Safety and Security Act (DQSA) requirements.
Quality Assurance reviews all documentation associated with manufacturing batches, from the materials used through the analytical and microbiological test results. Quality Assurance also reviews all test results for personnel and environmental monitoring to ensure expectations are met and tests conform to QuVa’s specifications for release. A Certificate Of Analysis (COA) is created for each batch. Retention samples are pulled from every batch and stored at QuVa.
We use barcode tracking to follow the movement of your product all the way through our facility to delivery at your hospital. Shipping tracking information is emailed to customers as part of each shipment notification.