Our quality system spans sourcing, compounding, testing, and release. We document every step so providers have confidence and patients have consistency.
Facilities & Environmental Controls
ISO-classified cleanrooms supporting sterile and non-sterile workflows
USP 795/797/800 compliance with routine environmental and surface monitoring
Calibrated equipment and preventive maintenance schedules
Ingredients & Suppliers
FDA-approved active ingredients from qualified, FDA-registered suppliers
USP/NF-grade excipients with lot traceability and COAs on file
Compounding Process Controls
Master formulation records & batch records
In-process checks, weight verification, and visual inspection
Aseptic technique training and media-fill qualifications where applicable
Testing & Release
Sterility and endotoxin testing when required by risk level and beyond-use dating
Potency/assay testing on select preparations per SOPs