OurPharma’s vendors, suppliers and service providers are evaluated through a robust Vendor Qualification Program via a risk-based approach for selection, auditing, approval and qualification. For example, suppliers of bulk Active Pharmaceutical Ingredients (APIs) and excipients are subject to both initial and ongoing confirmatory testing requirements. All confirmatory testing of APIs and excipients is performed by a qualified FDA registered contract laboratory.

Initial qualification testing is performed on each raw material attribute relevant to the specifications established for the compounded product, such as ID, assay, pH, endotoxin, chromatographic purity, residue on ignition, and residual solvents. Once qualified, ongoing confirmatory testing, including but not limited to ID, assay and endotoxin, of each lot and shipment of bulk raw materials is performed to ensure maintenance of continuous quality standards prior to permitting use of these materials in commercial production.