Expanding Access to Higher Quality
Office Use Compounds
Our commitment to patient safety centers on manufacturing compounded medications with the highest quality materials, technology and quality control processes possible. We are routinely inspected by the FDA, DEA and State Boards of Pharmacy to ensure compliance to cGMP standards and 503B guidance of The Drug Quality and Security Act. We leverage 17 years of compounding expertise and quality processing to deliver the highest level of patient care and patient safety possible for each and every product we deliver.
Atlas is a state-of-the-art 503B facility built with ISO 5 class hoods, ISO 7 class clean rooms and 24/7 environmental monitoring with high efficiency particulate air quality. Strict adherence to protocols and procedures for environmental monitoring and testing are followed 24/7. All equipment, testing areas and clean rooms are environmentally monitored, documented and cleaned daily. Our compliance to 503B facility design standards for sterile, non-sterile, controlled and non-controlled medications assures the highest level of patient safety and product quality.
The cornerstone of quality assurance and product safety at Atlas is adherence and compliance to cGMP regulations. Our quality assurance and quality control practices monitor all product preparations, source material testing, product stability testing, release requirements to ensure we are compliant to cGMP federal regulations. Our compliance to cGMP standards ensure all workflow systems follow proper design, monitoring and control of manufacturing processes and workflow efficiencies.
All medications are compounded, tested, quarantined and finished in a facility that is environmentally controlled and monitored 24/7. Product labeling, expiration dating, packaging and appropriate shipping controls are in place to comply with state and federal regulations to assure product quality and patient safety.
Robust quantitative stability-indicating studies provide data to define shelf life and expiration dates. All testing procedures, material sourcing and stability studies strictly comply with both federal and state regulations. Our method development processes include bioburden, sterility, endotoxin, potency, preservative effectiveness and particulate monitoring to validate shelf life dating and product quality standards. We have fully compliant quality control procedures in place for all source measurements, material weighing, and 100% visual inspection on all finished product.