Quality
LicensesOur commitment to patient safety combines utilization of the highest quality materials available, cutting edge technology, and quality assurance process controls that provides the right drug, right concentration, right route of administration for the right patient every time. As a national leader in sterile compounding, Empower Pharmacy has been committed for the last 8 years to developing quality processes that ensure the highest level of safety for patients.
Empower Pharmacy is designed and operated to meet cGMP standards. Furthermore, Empower Pharmacy adheres to the guidance provided by under section 503B of The Drug Quality and Security Act. We are regularly inspected by the State Boards of Pharmacy, DEA, and FDA to assure compliance. The key to providing safe sterile compounded products resides in using the principles of aseptic technique throughout the compounding process. This allows us to maintain the highest degree of supply chain integrity and compliance with state and federal regulations.
cGMP
Empower Pharmacy’s products are compounded under a comprehensive quality system that supports and sustains robust quality systems consistent with cGMP regulations. Quality Assurance and Quality Control (QA/QC) programs monitor the quality of our preparations through testing, documentation, and release and ensures compliance with applicable state and federal regulations. Our custom compounding services meet cGMP requirements for pharmaceutical compounding of sterile preparations. All our compounded sterile products undergo pH, particulate, preservative effectiveness, potency, endotoxin, and sterility testing as per USP.
Empower Pharmacy 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.
Facilities
All aseptic manipulations at Empower Pharmacy are performed in ISO 5 class hoods inside ISO 7 class cleanrooms supplied with High Efficiency Particulate Air (HEPA). Cleanrooms and laminar airflow hoods are certified for operational efficiency every 6 months by an independent agency. Environmental testing is performed regularly, monitored, and acted upon according to strict protocols. Daily clean down procedures are followed and documented.
Stability Studies
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 USP guidelines. Certificates of Analysis are received from manufacturers for ingredients used in 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 are reviewed by our quality control team and a compounding pharmacist before release.