Our team of quality specialists is led by a management team with extensive pharmaceutical experience and CQA certification through ASQ.
- Ensures compliance with applicable federal, state and local regulatory agencies (e.g., FDA OTC Drug cGMPs, CA Department of Health Services Food and Drug Branch, EPA, AQMD).
- Performs internal and vendor certification audits.
- Conducts raw material/component inspections, in-process inspections and documentation reviews.
Quality Control Laboratory
- Performs physical, organoleptic, analytical and microbial testing. All products manufactured at Levlad are tested by the QC lab prior to release.
- Staffed with experienced, degreed personnel capable of performing all the required tests for incoming raw materials and Levlad manufactured final products in a cGMP compliant manner.
- The Analytical department conducts validated assay testing of the actives in OTC products.
- The Microbiology department is capable of performing preservatives effectiveness testing, in addition to routine plate count testing.
- All incoming raw materials are tested using FT-IR, HPLC and/or GC.
- Conducts stability testing on all products through production. Long term stability studies are performed for OTC drugs as per 21 CFR 211 requirements.