Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework

by:Dora Kourti, PhD  The Role of Models in Quality by Design (QbD) was one of the topics chosen for Points to Consider by the International Conference for Harmonization (ICH),...
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Evaluation of Impact of Statistical Tools on Process Performance Qualification (PPQ) Outcomes

In 2011, FDA issued a “Guidance for Industry Process Validation: General Principles and Practices Guidance,” which calls for a lifecycle approach to process validation and heavily references the use...
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