Quality Assurance
We take it serious.
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.
FDA 503B Compliant
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.
Current Good Manufacturing Practices (cGMP)
Compounding:
MedisourceRx products are compounded under current good manufacturing practice (cGMP) regulations.
Quality Assurance Program:
Quality Assurance Program encompasses all aspects of preparation and testing to ensure accuracy and precision in weighing, measuring, and methods of sterilization.
Quality Controls:
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.
Environmental Monitoring:
Strict environmental monitoring and evaluation procedures for clean-room areas and personnel.
Our Team
Our Promise to You:
- All employees are required to complete a didactic and hands-on training programs before performing any duties.
- Staff competency is evaluated prior to pharmacy compounding, which includes a thorough training on each standard operating procedure, USP <797>, cGMP, cleaning and disinfection, storage and handling, facilities and equipment, garb, aseptic technique and preparation, process validation, expiration dating, labeling, end-preparation evaluation, and documentation.
- Employees involved in compounding sterile preparations participate in media-fill testing according to USP Chapter <797> standards.
- Training is given to the employees on a routine basis to ensure overall quality and continuous development of our employees.
Our Facilities
Aseptic Techniques:
All aseptic techniques are performed in ISO 5 class hoods inside ISO 7 class clean-rooms supplied with High Efficiency Particulate Air (HEPA).
Maintenance Schedules:
Clean-rooms and laminar airflow hoods are certified for operational efficiency every 6 months by an independent agency.
Environment Control:
Environmental testing is performed regularly, monitored, and acted upon according to strict protocols.
Disinfecting Maintenance Schedule:
Daily, weekly, and monthly cleaning procedures are followed and documented.
Labels
Our Labeling Practices:
- Designed to enhance patient safety.
- Include the name, dosage form and strength of the drug; lot number, volume, date that the drug was compounded, beyond use date, storage and handling instructions, the statement “compounded drug”, the name, address, and phone number of MedisourceRx, the statement “not for resale” or “office use only” where applicable, and a list of active and inactive ingredients identified by established name and the quantity or proportion of each ingredient.
- Bar codes are easily read by scanners, commonly used in point-of-care medication administration systems, smart pump technology and automated dispensing machines.
- Quality controls have been established for issuing labels, examining issued labels, and reconciliation of used labels to prevent mix-ups.
- All labeled drug products are examined for accuracy and thoroughness before release.
Container and Closure
Sterility:
Capable of ensuring the sterility and integrity of the product until it is administered to a patient.
Closure Integrity:
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.
End-Product Testing
Batch Processing:
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.
Beyond Use Dating
Our Process:
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:
Sterility is ensured through process validation, sterile closure integrity testing and ongoing preparation monitoring.
Certificate Of Analysis
Our Promise:
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.
Available Upon Request:
A Certificate of Analysis of a product produced at MedisourceRx can be provided upon request.