Quality Assurance
Our Standards
We maintain the highest pharmaceutical standards with rigorous testing, continuous monitoring, and accredited quality systems.
Compliance Framework
Every aspect of our operation is governed by industry-leading standards and certifications.
USP 797 Compliance
Full adherence to the United States Pharmacopeia chapter on sterile compounding, governing personnel training, environmental monitoring, and quality assurance.
USP 800 Compliance
Complete compliance with hazardous drug handling standards including engineering controls, PPE requirements, and safe disposal protocols.
HEPA Filtration
ISO Class 5 primary engineering controls with HEPA-filtered air providing 99.99% particulate removal for an ultra-clean compounding environment.
Potency Testing
HPLC and UV spectrophotometry verification ensures every compound meets exact concentration specifications within ±5% of label claim.
Environmental Monitoring
Continuous monitoring of temperature, humidity, pressure differentials, and particulate counts with automated alert systems.
Documentation Control
Complete batch records, audit trails, and COAs maintained for every compound with full traceability from raw material to final product.
Quality Control Pipeline
From Raw Material to Release
Raw Material Receipt
USP <1058>COA verification, identity testing, and quarantine until approved.
Pre-Compounding QC
ISO 14644-1Environmental monitoring, equipment calibration, and garbing verification.
Aseptic Compounding
USP <797>Sterile preparation under ISO Class 5 conditions with trained personnel.
In-Process Checks
cGMPWeight verification, visual inspection, and pH testing at critical steps.
Finished Product Testing
USP <71> <85>Potency assay, sterility testing, endotoxin analysis, and particulate matter.
Quality Release
Triple-CheckPharmacist review, labeling verification, and final quality approval.