High standard of quality and safety

Quality isn’t just something we talk about

It is entrenched from the ground-up in every process, system and facility QuVa has–in what we build, to who we employ, and how we work.

QuVa places equal importance on every step performed throughout the lifecycle of our products, from design and validation, to monitoring and continuous improvement. We use end product testing to verify the performance of our preparations, not simply to justify their release. We ensure our operation is in a state of control and delivering the highest quality results at every step, because we know you are supporting a patient in the operating room, in the labor and delivery unit, or in the ICU, in need of the products we make.

cGMP rigor and full transparency

We encourage customer visits and audits, and we initiate independent third-party audits periodically for each facility.

QuVa follows compliance with the FDA written 503B GMP guidance requirements, 21 CFR part 210-211 GMP requirements, and the 2004 aseptic processing guidance for the manufacturing industry. The 503B Guidance are cGMP standards that are at a higher level of quality and safety than that of the USP <797> for outsourcing facilities. By adhering to the 503B Guidance, QuVa meets or exceeds the expectations defined in USP <797>.

Regulatory Compliance

QuVa adheres to the governance of the FDA, DEA, OSHA, and the appropriate state BOP.

Integrated Quality Management Systems

QuVa’s robust approach to compliance through the design of integrated processes ensures adherence to agency expectations. These Quality Management Systems provide requirements to ensure we are operating in a compliant manner.

Quality Control System

QuVa focuses on cGMP compliant laboratory operations, environmental/personnel monitoring, sterility assurance, product release testing by USP (sterility, potency, and endotoxin), & stability and retention programs.

Materials System

QuVa focuses on supplier & inventory management including first-in/first-out usage, warehouse operations, and good distribution practices.

Quality Assurance System

QuVa focuses on training, internal & external auditing, complaint investigation, continuous improvement through corrective & preventive action programs, and documentation, investigation, & facility-level change management.

Production System

QuVa focuses on in-process monitoring, aseptic technique, and right-first-time processing throughout the manufacturing process from preparation to compounding visual inspection to labeling to packaging.

Validation Systems

QuVa focuses on equipment qualification, cleaning and disinfection qualification, process qualification, container/closure integrity, process simulation program, and new product qualification.

Regulatory & Pharmacy Systems

QuVa focuses on licensing, new formulary change management, notifications, adverse effects, recalls, initiation of new drug and labeling codes, and biannual product listing.

Facilities Systems

QuVa’s facilities focus on HVAC, preventative maintenance, calibrations, demand work order management, capital projects, pest controls, & security.

Foundation: People

Our compounding technicians are the most experienced in the industry and are comprehensively trained on media fill & gowning qualification, aseptic technique, operating flows, adherence to cGMP, strict garbing, and cleaning.