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Creating Quality by Design/Process Analytical Technology (QbD/PAT) Management Awareness

Article published in Pharmaceutical Engineering, May/June 2008

Summary
The International Society for Pharmaceutical Engineering (ISPE) maintains several Communities of Practice (COP) which's task it is to encourage the exchange of technical information, improve communication and networking within the interest groups on a local level. The Process Analytical Technology (PAT) COP of the ISPE DACH-Affiliate (Germany, Austria and Switzerland) has written a PAT awareness document, which explains how QbD (Quality by Design) / PAT management awareness can be created.

This article, written by Christian Woelbeling, Director of Marketing and Sales at Werum Software & Systems, and the Regional PAT COP from ISPE DACH summarizes the first four chapters of the PAT awareness document.


Copyright ISPE 2008. Reprinted with permission from ISPE.
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