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.
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.
Batch record review
COA issuance
Lot release
Additional responsibilities
- Hosting regulatory and client audits;
- Complaint Handling Unit;
- Material Review Board;
- Annual product reviews.
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