Quality Checklist
Our Processes:
- Only pharmaceutical grade chemicals/raw materials from FDA registered suppliers are utilized in our compounds.
- Certificates of Analysis from manufacturers are received and reviewed for ingredients used in compounded preparations.
- All compounds undergo a rigorous process validation study, ensuring reproducibility and reliability of the formulation.
- Facility designed and operated with facility layout, room separation, and process flow considered in a manner to prevent the influx of contamination from adjacent areas and rooms of lower air quality.
- We utilize Class 100 laminar airflow hoods inside our state-of-the-art class 10,000 clean rooms achieving 0.2 micron filtration.
- We perform method suitability and preservative effectiveness testing on our preparations.
- Potency, sterility, fungal, and endotoxins of finished compounds are tested by a 3rd party FDA registered laboratory before being released,
- Sterile compounding is overseen by trained and licensed compounding pharmacists.
- 35 foot ceiling shipping/receiving warehouse with controlled temperature and humidity for storage utilizing FedEx and USPS systems for shipments.
- Our robust inventory management system can trace an order back to the original formula log sheet and the source of its ingredients.
- Fully licensed, bonded and insured.
- The pressure, temperature, and humidity of the clean-room is continuously monitored and include built-in alarms to detect excursions.
- The clean room and laminar airflow hoods are certified semiannually by an independent company.
- Smoke studies of all our clean rooms and hoods are conducted under dynamic conditions to qualify them for use.
- Viable air, surface and personnel sampling is performed daily in the clean-room.
- Post-filtration filter-integrity testing is performed on all compounds sterilized via filtration.
- The clarity, appearance, pH, and particulates are tested on all injectable medications.