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Quality Assurance

FDA Listed Product Lines

Cantrell Drug Company’s FDA listed product lines are compounded under a comprehensive quality system model that supports and sustains robust quality systems consistent with cGMP regulations. These preparations are compounded in an FDA registered facility using applicable current Good Manufacturing Practices. Cantrell's Quality Control and Quality Assurance (QC/QA) program monitors the quality of Cantrell’s preparations through testing, documentation and continuous quality improvement procedures and ensures compliance with applicable state and federal regulations.

Click on the link below to be directed to the FDA's website for Drug Firm Annual Registration Status Query and then type in Cantrell Drug Company. http://www.fda.gov/cder/dfars/docs/querydrls.htm

Custom Compounding Services

Cantrell's custom compounding services exceed USP ‹797› requirements for pharmaceutical compounding of sterile preparations. Our products undergo potency, endotoxin and sterility testing as per USP. Cantrell Drug Company utilizes a formal QA program, which encompasses all aspects of preparation and testing to ensure accuracy and precision in weighing, measuring, and methods of sterilization. In addition, quality controls are in place to confirm the absence of particulate matter, appropriate color and clarity, correct calculations, labeling accuracy, beyond use date assignment, and packaging/storage requirements. We also follow strict environmental monitoring and evaluation procedures for our cleanroom areas and personnel.

Highly Specialized

All procedures are performed by highly trained and qualified licensed pharmacists and technicians specializing in sterile preparation. All pharmacy personnel responsible for preparing sterile preparations receive both didactic and experiential training in sterile preparations and are routinely validated for proper aseptic technique. In-house rapid microbiological technology provides an immediate, highly sensitive assessment of compounded preparation sterility.

Risk Level III Compounding

Cantrell Drug Company meets or exceeds the requirements necessary to prepare high-risk sterile preparations according to USP Chapter ‹797›. Quality Assurance processes within this risk level are the most stringent of the drug preparation classifications designated by USP. Documented quality assurance policies and procedures provide the foundation for all processes performed at Cantrell Drug Company in order to ensure the final preparation has the identity, strength, purity, and quality that it is required to possess.

Certified Cleanrooms

All aseptic manipulations at Cantrell Drug Company are performed in ISO 5 class hoods inside ISO 7 class cleanrroms supplied with High Efficiency Particulate Air (HEPA).  Cleanrooms and laminar airflow hoods are certified for operational efficiency every 6 months by an independent certification agency. Environmental testing is performed regularly, monitored, and acted upon according to strict protocol. Daily clean down procedures are strictly followed and documented.

Potency and Rapid Microbiology Testing

Appropriate end-preparation testing, including sterility testing, is performed according to USP ‹797› & ‹71› guidelines. Rapid Microbiology via Laser Scanning Cytometry is offered for most aqueous solutions, providing immediate, same-day sterility results.

Other Controls

Quantitative analysis is performed per USP requirements on each batch to determine concentration of the active ingredient(s). Potency testing is performed by an independent, FDA registered laboratory.  Ingredients used in compounding procedures are determined to be stable, compatible, and appropriate for use, according to manufacturers' and USP guidelines. Certificates of Analysis are received from manufacturers for ingredients used in pharmacy-compounded preparations. Tests are performed according to USP ‹797› & ‹71› guidelines. Components and finished preparations undergoing end-preparation testing remain in quarantine until testing results are received and reviewed by Quality Control and a compounding pharmacist.