Patient safety is a priority for MedisourceRx. As a leader in quality sterile preparations, MedisourceRx is committed to fulfilling quality processes as guided by USP <797> and current Good Manufacturing Practices (cGMP) that ensure the highest level of safety for patients. MedisourceRx only uses the highest quality materials available to the drug industry, advanced pharmaceutical technology, and robust quality systems to ensure patient safety.
Our employees, equipment, facilities, training, processes, and compliance with state and federal regulations ensure that MedisourceRx is the leading 503B Outsourcing Facility in the nation.
MedisourceRx products are compounded under current good manufacturing practice (cGMP) regulations.
Quality Assurance Program encompasses all aspects of preparation and testing to ensure accuracy and precision in weighing, measuring, and methods of sterilization.
Quality controls are in place to confirm the absence of particulate matter, appropriate color, clarity, correct calculations, labeling accuracy, beyond use date assignment, and packaging/storage requirements.
Strict environmental monitoring and evaluation procedures for clean-room areas and personnel.
All aseptic techniques are performed in ISO 5 class hoods inside ISO 7 class clean-rooms supplied with High Efficiency Particulate Air (HEPA).
Clean-rooms 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, weekly, and monthly cleaning procedures are followed and documented.
Capable of ensuring the sterility and integrity of the product until it is administered to a patient.
Closure integrity testing confirms that our container, closure, and packaging systems provide adequate protection against external factors in storage, shipment, and use that could cause contamination or deterioration of the finished product.
We test and hold every batch of medication that is compounded at MedisourceRx before we release it for use.
This quality assurance program ensures every compound produced at MedisourceRx meets specifications for sterility, endotoxin and potency tests prior to release.
MedisourceRx bases its beyond use dating on stability testing to ensure safety, stability, reliability and efficacy. Testing, specific to drug, concentration, fill volume, container and diluents, ensures effective therapy through the labeled expiration date.
Sterility is ensured through process validation, sterile closure integrity testing and ongoing preparation monitoring.
Every sterile compound is tested in-house or by a 3rd party FDA registered analytical laboratory for container-close integrity, method suitability, pH, particulate, clarity, appearance, preservative effectiveness, sterility, endotoxin and potency according to USP <51>, <71>, <85>, <788>, <797>, and <1207> guidelines.
A Certificate of Analysis of a product produced at MedisourceRx can be provided upon request.
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