Ensured Quality

Ultrum Labs maintains proven procedures and activities to monitor, measure, analyze, and improve quality across the entire company.

Such activities include internal audits, data review, non-conforming data control, and the monitoring of events that could directly influence the quality of the products manufactured at Ultrum Labs.

Formulation

Concept to commercialization begins with formulation/reformulation of a product that fulfills a need.

Manufacturing

We are commitment to product quality, consistency, and integrity.

Packaging

Our assembly lines are designed to make products ready for commercialization.

Analytics

Our experienced quality control team works to bring clients the highest level of analysis.

Facility

Our facility is regularly inspected by regulatory authorities, including the U.S. Food and Drug Administration, Drug Enforcement Administration, Florida Department of Agriculture, Florida Department of Business & Professional Regulation.

Our facility is also frequently audited by existing and new customers. We welcome these audits and incorporate any feedback received for continuous improvements to our Operations and Quality Assurance.

In addition, Ultrum Labs is committed to continuous investments in our facility, technologies, and equipment to improve the quality of our services and products. We provide our employees with ongoing cGMP and regulations compliance training. Our Quality Unit team has a wide range of solid experience working in the pharmaceutical industry.

Quality Unit Functions

Approve documents

  • INV, DEV, VAR, OOS, OOT, CC, CAPA;
  • Manufacturing validation protocols & reports;
  • Packaging validations protocols & reports;
  • Analytical method validation/verification protocols & reports;
  • Stability protocols & reports;
  • IQ/OQ/PQ protocols & reports;
  • Executed PM/Cal;
  • SOP’s;
  • Validation and commercial MBR’s;
  • Validation and commercial PWO’s.

Approve laboratory data

  • Data integrity;
  • Methods;
  • Specifications;
  • Results

Packaging Components

  • Measurement testing;
  • Functionality testing;
  • Visual inspection against in-house standard.

Labels

  • Verification of quantity of labels received;
  • Visual inspection against in-house standard;
  • Storage in an accessible and environmentally controlled room.

Chemical Raw Materials

  • Aseptically sampled in sampling room for laboratory testing.

Additional responsibilities

  • Verification of quantity of labels received;
  • Visual inspection against in-house standard;
  • Storage in an accessible and environmentally controlled room.

COA issuance

Lot release

Batch record review