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Private Labeling
Internal audits, data reviews, non-conforming data control, and monitoring events that may impact product quality.
Quality unit focus
Lohxa is dedicated to maintaining the highest quality standards in our operations. With a focus on safety and compliance, our expert team ensures that every product is reliable and meets industry regulations.
Approve documents
- INV, DEV, VAR, OOS, OOT, CC, CAPA;
- Manufacturing validation protocols & reports;
- Packaging validations protocols & reports;
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 resposnsibilities
- Verification of quantity of labels received;
- Visual inspection against in-house standard;
- Storage in an accessible and environmentally controlled room.
COA issuance
Batch record review
Lot release
Our facility is regularly inspected by regulatory authorities, including the U.S. Food and Drug Administration, Drug Enforcement Administration.
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.
Lohxa 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.
Where to Find us?
Address
7 Pioneer Drive, North Oxford, MA 01537
Feel free to Contact us.
We’ll be glad to hear from you!
