What’s Inside: A Summary of the ISPE Biopharmaceutical Manufacturing Facility Guide, Second Edition

By Mark von Stwolinski The first edition of the ISPE Biopharmaceutical Manufacturing Facilities Baseline Guide was issued in June 2004. Its concepts have been phased-in over the past several...
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How Does Facility Layout Affect Segregation Strategies in NextGen Pharmaceutical Manufacturing Facilities?

Complete separation of process and products from each other within a biopharmaceutical manufacturing facility is an operational and regulatory imperative. But does that necessarily mean physical separation? Or can...
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