FDA Accepts Updated DMFs from Celsis

Celsis International 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. “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.

The FDA accepts DMFs from suppliers 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.

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 in preparation for review and approval.