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Published: Tuesday, September 27, 2005 - 22:00 The FDA encouraged ISPE to develop a clearer definition of the elements that characterize RABS technology to assist the agency and industry professionals to understand it. The International Society for Pharmaceutical Engineering provides pharmaceutical manufacturing professionals with opportunities to develop technical knowledge, exchange practical experience and collaborate with global regulatory agencies. It has affiliates and chapter in 19 countries. For more information, visit www.ispe.org. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.ISPE Releases Definition of RABS
Because of the great confusion about restricted access barrier systems (RABS), the U.S. Food and Drug Administration and the International Society for Pharmaceutical Engineering have released a definition paper to elucidate industry professionals on the topic.The paper includes key elements of RABS, a type of barrier system for aseptic processing of pharmaceutical products that reduces or eliminates interventions. The ISPE paper defines it as including the following elements:
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