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The International Conference on Harmonisation (ICH) has prepared three important guidance documents related to the development and implementation of PAT and QbD into a regulated environment. These documents are
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These form the basis of the ICH Q8/Q9/Q10 triangle. Most of the emphasis of these guidance documents is on the definition and maintenance of the Design Space. The Design Space is multivariate in nature and therefore The Unscrambler® GenX family of products provides the most comprehensive, flexible and adaptable solution for any company looking to implement PAT/QbD. Application areas of The Unscrambler® GenX family of products are described in the diagram below, with relevance to the ICH Q8/Q9/Q10 triangle.
The Unscrambler® GenX suite of products for PAT & QbD
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