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Cantrell Drug Company’s FDA Registered Product Lines are produced under a comprehensive Quality System model that supports and sustains robust quality systems consistent with cGMP regulations. These products are produced in an FDA registered facility using 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
Cantrell's Custom Compounding Services exceed USP 797 requirements for Pharmaceutical compounding - Sterile Preparations. Our products undergo potency, endotoxin and sterility testing as per USP. Cantrell Drug Company utilizes a formalized QA program, which encompasses all aspects of preparation and testing to ensure accuracy and precision of weighing and measuring, and methods of sterilization. In addition, quality controls are in place to confirm the absence of particulate matter, appropriate color and clarity of product, 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.
All procedures are performed by highly trained and qualified licensed pharmacists and technicians specializing in sterile product preparations. All pharmacy personnel responsible for preparing sterile products receive both didactic and experiential training in sterile product preparations and are routinely validated for proper aseptic technique. In-house rapid microbiological technology provides immediate, highly sensitive assessment of aseptic techniques.
Cantrell Drug Company meets or exceeds the requirements necessary to prepare high-risk sterile products according to USP Chapter ‹797›. Quality assurance processes within this risk level are the most stringent of the drug product 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 product has the identity, strength, purity, and quality that it is represented to possess.
All aseptic manipulations are performed in a Class 100 environment using High Efficiency Particulate Air (HEPA). Cantrell Drug Company's state-of-the-art facility includes two certified ISO Class 5 cleanrooms and one certified ISO Class 6 cleanroom. Cleanrooms and laminar airflow hood are certified for operational efficiency every 6 months by an independent certification agency. Weekly environmental testing is performed, monitored, and acted upon as necessary. Daily clean down procedures are strictly followed and documented.
Appropriate end-product 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-accurate down to one single microbe. 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 chemicals used in pharmacy-prepared medicines. Tests are performed according to USP ‹797› & ‹71› guidelines. Components and finished products undergoing end-product testing and remain in quarantine until testing results are received and reviewed by a compounding pharmacist.
