Exceeding standards is our standard
QuVa enforces the most detailed and comprehensive quality control testing measures in the 503B sterile compounding industry – our standards redefine the standard you should expect from your outsourced compounding partner.
We will never cut corners. QuVa’s company commitment to quality of preparation, product and testing, coupled with our accountability to our customers, comes from the very top and lives at all levels – each employee is empowered and responsible to own our proven quality and safety record.
We consider the required FDA standards for sterility, endotoxin and potency testing as the bare minimum. QuVa exceeds these standards with viable and non-viable particulate sampling results, as well as personnel finger-tip monitoring results with every batch, to ensure we provide the highest quality products to your hospital. QuVa will never use end product testing simply to justify a product’s release – no product is ever released at risk, EVER.
The Essential Tests We Perform
Pharmacy Services Oversight
Pharmacist-in-charge (PIC)
expertise throughout
our policies, processes,
procedures and
regulatory affairs
- Design, review, and approval of master documents and processes
- Review and approval of change controls
- State and federal regulatory and policy responsibility
- Clinical and drug information communications
- Translate current hospital setting experiences into operational continuous improvements
Industry-leading safety record
Every QuVa manufacturing facility has successfully completed its general inspection. QuVa operations are fully compliant with the new FDA compounding guidance.
- No FDA Warning Letters
- No FDA Regulatory Meetings
- No repeat 483 Observations
- No observations from DEA inspection
- In addition to FDA, no disciplinary actions from States Board of Pharmacy
Certified peace of mind
Patient safety is our primary concern, so our independent Quality Unit validates a Certificate Of Analysis (COA) showing actual results for each batch to evidence testing of endotoxin, sterility and potency, as well as environmental monitoring and personnel monitoring data, and that they fall within required specifications.
We verify through statistically significant sampling methods that the product leaving a QuVa facility is accurately prepared to the correct product specification.
