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Responding to Change in the Pharmaceutical Compounding Industry
A lot has happened in the world of sterile, compounded medicine in the past decade – from the creation of sections 503A and 503B in the Federal Food, Drug, and Cosmetic Act, to the complete overhaul of the USP <797> standards used to manufacture and test products. The role of a compounding pharmacist has expanded. Compounders must navigate how to create products with tighter oversight and shorter shelf-life. To do so, compounding pharmacists must become supply chain, manufacturing, and Quality Control experts.
Fagron Sterile Service’s plan to meet these challenges involved increasing control over their processes. To maintain ownership over product release testing, they created a QC microbiology laboratory to test sterility in-house. To ensure product made it to patients quickly, they made sure to implement a rapid sterility test method. Fagron chose to install the Celsis® Rapid Detection System by Charles River Laboratories, which cuts the traditional 14-day sterility test down to 6 days.
“Our collaboration with the Charles River team was instrumental in seamlessly validating and implementing the Celsis technology. Their expertise ensured that we met rigorous compendial standards and established a reliable framework for routine testing, reinforcing our commitment to excellence in pharmaceutical quality.”
Philip Smith, Director of Laboratory Services, Fagron Sterile Services
Charles River supported Fagron with the Celsis Complete Validation Package. This package was designed to meet the conservative standards of USP chapter <1223>, European Pharmacopeia section 5.1.6, and PDA Technical Report 33. The Charles River lab functioned as a contract laboratory, executing a test protocol using Fagron’s products and organisms specific to their manufacturing facility. Upon completion of the protocol, Fagron had robust data to support equivalency between Celsis and the traditional sterility test method.
The support also included on-site visits to perform training and complete installation and operational qualifications for the system. With this new method in place, Fagron can ensure their unique medicines make it to their patients up to 8 days faster. You can read more about their story in this case study.