Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 FDA Accepts Updated DMFs from Celsis | Contract Pharma

What are you searching for?

Sign in
Breaking News

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.

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

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.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics