USP Testing. Every Batch. Every Time.
At QuVa Pharma, we do more than meet the required standards for sterility, endotoxin and potency testing—we take end product testing to the highest level by testing every single batch, every time. With a Certificate of Analysis including actual results for each batch to evidence testing, you can be sure our methods are validated. And because no product is released at risk, you’ll have peace of mind before springing into action.
STERILITY TESTING USP <71>
- 14 Day Sterility Hold: Every batch tested for sterility and held for the duration of the test (minimum 14 days) prior to release.
- Method Suitability: Every formulation undergoes method suitability testing using full USP panel of 6 organisms to ensure the methodology is valid.
- Strict Sampling Guidelines Compliant with USP <71> requirement, the appropriate sample size is collected that is representative of the batch size.
ENDOTOXIN TESTING USP <85>
- Batch Testing: Endotoxin testing is performed on every lot regardless
- Endotoxin Limits: Established for every individual formulation based on the maximum dosage per hour, average patient weight and route of administration in accordance with USP <85>.
- Endotoxin Method Validation: Performed on every formulation to ensure that interfering factors in the formulation do not inhibit the functionality of the test and cause false negatives and that the sensitivity of the test is maximized.
- Batch Testing: Every batch is potency tested regardless
- Potency Range: Potency tested prior to release and expected to meet the minimum USP potency range of 90-110% of the label.
- Potency Testing Method: Performed using high performance liquid chromatographic analysis to ensure potency is accurate and precise.
EXTENDING BUD (BEYOND USE DATE)
- Comprehensive Stability Program: Each product is assigned a BUD established through a comprehensive stability testing program that meets 503B requirements. QuVa Pharma has established a program to extend BUDs for likely product candidates. This is accomplished through the stability program where product is tested to specification over the desired BUD timeline.
HOUSE OF QUALITY
- QuVa Pharma remains committed to building a house of quality, placing equal importance on every step performed throughout the lifecycle of a drug, from design and validation to monitoring and continuous improvement. End product testing is a verification of performance not justification for release.
- QuVa facilities are registered with the FDA as a 503B Outsourcing of human drug. As a result of being registered with the FDA, QuVa follows compliance with the FDA written 503B GMP guidance requirements, part 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>.
- QuVa welcomes customer audits and initiates an independent third party audit periodically for each facility.
- 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
Our People are our most valued asset. QuVa employs the most experienced compounding technicians (5-10 years of IV compounding experience). Our compounding employees are required to go through a comprehensive training that includes media fill qualification, gowning qualification, strict garbing, and cleaning training. This rigorous training is conducted by qualified trainers. Aseptic Process Monitors (experienced employees with extensive experience with aseptic techniques) provide oversight to compounding technicians by facilitating appropriate aseptic techniques, operating flows and adherence to cGMP. Experienced leadership team balancing pharmacy operations with FDA aseptic processing requirements and current Good Manufacturing Practices to 21 CFR 210-211.