Celsis International has announced it has recently updated its Drug Master Files with the FDA to include information on testing both non-sterile and sterile raw materials, in-process solutions and finished goods on the Celsis system.
“A growing number of our Rapid Detection customers are using their Celsis systems to confirm sterility,” said Judy Madden, Vice President of Celsis International. “By updating and expanding the information available in our DMFs regarding micro limits and sterility testing, we are helping to simplify and, ideally, speed the regulatory review process,” she explained.
Celsis offers a variety of resources to help customers with their filings, including the assistance of an experienced regulatory compliance manager. “We understand the economic value to our customers in getting their products to market faster,” said Madden. “Companies won’t realize the full financial benefits of rapid detection unless their systems are successfully validated. For this reason we have always delivered outstanding global scientific, technical and customer support as an integral and important part of every Celsis system.”
The FDA accepts DMFs from suppliers like Celsis that can be referenced by pharmaceutical companies submitting new, supplemental or amended drug applications. The DMF is a technical document that contains reference support data as well as proprietary information about manufacturing and formulation. Celsis has two DMFs, the originals dating back to 2006, for the RapiScreen™ and AKuScreen™ assay families. The newly updated DMFs include data for specificity, limit of detection, robustness, ruggedness and equivalence, for use with both microbial limits and sterility testing. They can be used to supplement or streamline the validation of a Celsis system, saving companies’ time in preparation and saving the FDA time in review and approval.
