Celsis International updates Drug Master Files with FDA

NewsGuard 100/100 Score

Celsis International, the global leader in rapid microbial detection, announced it has recently updated its Drug Master Files with the U.S. Food & Drug Administration (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.

Source:

Celsis International

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Study exposes food insecurity among graduate students and postdocs