House of Quality

The cornerstone of our solution, and yours

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.

Our quality is derived from rigorous cGMP processes and control systems through each step of manufacturing and testing. Product doesn't come to you until it passes all established specifications

David Short,
Vice President of Quality, QuVa Pharma

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>.

Quality assurance

Regulatory Compliance

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

Integrated Quality Management Systems

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

Quality Control System

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

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

Quality Assurance System

Focuses on training, documentation management, facility-level change management, internal and external auditing, investigation management, complaint investigation, continuous improvement through corrective and preventive action program.

Production System

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

Validation Systems

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

Regulatory/Pharmacy Systems

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

Facilities Systems

Focuses on HVAC, preventative maintenance, calibrations, demand work order management, capital projects, pest controls, security.

Foundation: People, Culture, Values

Our compounding technicians are the most experienced in the industry, and complete rigorous and comprehensive training under the supervision of qualified trainers on media fill qualification, gowning qualification, strict garbing, and cleaning training. Employees with extensive experience with aseptic techniques provide oversight to compounding technicians by facilitating appropriate aseptic techniques, operating flows and adherence to cGMP. Our experienced leadership team balances pharmacy operations with FDA aseptic processing requirements and current Good Manufacturing Practices to 21 CFR 210-211.
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