ISPE releases RABS definition

Published: 17-Mar-2006


A definition paper on restricted access barrier systems (RABS) used in cleanrooms has been published by the global society of pharmaceutical manufacturing professionals, ISPE, in co-operation with the US FDA.

The paper provides a definition of RABS for the pharma industry, in order to reduce the level of confusion about the key elements of RABS and their regulatory requirements, specifically in relation to how it differs from other barrier isolation systems. The FDA encouraged ISPE to develop a clearer definition of the elements that characterise RABS technology to assist the Agency and industry professionals in reaching an understanding on requirements for RABS.

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