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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Regulatory Matters

ISPE’s Drug Shortages Prevention Plan Task Team Chair provides insight on the Team’s Approach

François Sallans, Chair of the ISPE Drug Shortages Task Team, is interviewed about ISPE’s Drug Shortage Prevention Plan in the September/October 2014 issue of Pharmaceutical Engineering.  In the interview,...
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