Friday, September 23, 2005

RABS Definition Paper Finalized

A restricted access barrier system (RABS) is a type of barrier isolation system that includes several specific characteristics; however, there is great confusion in the industry about RABS and how they differ from other forms of advanced aseptic processing.

In order to assist regulatory and industry professionals in reaching an understanding of the requirements for RABS, the FDA encouraged ISPE to provide a clearer definition of the elements that characterize RABS technology. Following ISPE's annual Barrier Isolation Technology Conference (part of the 2005 Washington Conferences in June), a group of attendees, speakers, and organizers met to create a definition white paper for RABS. The team posted the draft paper for public comment on the ISPE Web site during July and submitted a final version to the FDA. Released on 16 August, the positioning paper defines RABS for the industry and describes the "quality by design" and operational characteristics that must be present to constitute a RABS.

"I think this group's constructive work in describing RABS will be helpful to both industry and FDA. This appears to be the first, and certainly the most current and comprehensive, RABS definition offered by a technical organization," said Rick Friedman, Team Leader for Guidance and Policy at the FDA's Center for Drug Evaluation and Research. "Now, companies will be able to start sterile facility design discussions with a concrete definition to refer to. I expect this contribution to be an instrumental step toward reaching consensus on a formal definition."

link to article

1 comment:

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