Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Celsis International, a provider of rapid microbial detection, has updated its Drug Master Files (DMFs) with FDA to include information on testing both non-sterile and sterile raw materials, in-process solutions and finished goods on the Celsis system.
Subscribe to our email newsletter
Celsis helps customers with their filings by offering various resources including the assistance of regulatory compliance manager. The DMF is a technical document that contains reference support data as well as proprietary information about manufacturing and formulation.
The FDA accepts DMFs from suppliers like Celsis that can be referenced by pharmaceutical companies submitting new, supplemental or amended drug applications.
Accoridng to Celsis, it has two DMFs, 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.
Judy Madden, vice president of Celsis International, said: “A growing number of our rapid detection customers are using their Celsis systems to confirm sterility. 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.”