Quality

Quality Assurance

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.