Quality Testing & Pharmacy Services

Every single batch, every single time

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.

David Short
VP Quality, QuVa Pharma, Inc

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.

When the team of QuVa professionals releases a product for shipping, they have personally verified that it has been prepared exactly as required by the process and product record.
The Essential Tests We Perform

Sterility Testing

Sterility Testing detects the presence of bacteria, yeast and mold to ensure the probability is less than one out of one million that it is contaminated with replicating microorganisms.

USP <71> <1223> Validated Testing

Every batch tested for sterility by BioMereiux Scan RDI; validated to USP <1223> and <71>.

Method Suitability.

Every formulation undergoes method suitability testing using full USP <71> 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>

Endotoxin Testing detects the presence and concentration of bacterial endotoxins in drugs and biological products to ensure they are free from contaminants.

Batch Testing
Endotoxin testing is performed on every lot.

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.

Potency

UPLC vs. HPLC

QuVa exceeds the standard required in potency testing by using Ultra Performance Liquid Chromatography (UPLC) vs standard High Performance Liquid Chromatography (HPLC) as an analytical technique to separate, identify, and quantify components in a mixture to ensure they meet the specific quality and purity levels.

Batch Testing
Every batch is potency tested.

Potency Range
Potency tested prior to release and expected to meet approved specifications following USP.

Potency Testing Method
Performed using ultra performance liquid chromatographic analysis to ensure potency is accurate and precise.

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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 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.

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