Knowledge

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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ISPE’s CGMP Conference Continued with a Provocative Discussion on Process Validation

Jenn Walsh, Associate Director Manufacturing Technology, Bristol Myers Squibb moderated a night session on process validation. Dafni Bika, PhD, VP, Global Manufacturing and Supply, Bristol Myers Squibb, discussed the...
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