Opportunities for improvement in managing pre-PPQ biologic product knowledge

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Beth Fulton1, Theo Zacharatos2, Igor Gorsky3

  • 1QRM Consultant, ValSource Inc., USA bfulton@valsource.com.

PDA Journal of Pharmaceutical Science and Technology
|October 16, 2025
PubMed

Keywords:
Biologic ProductCritical Quality Attributes (CQAs)Data IntegrityICH Q10Knowledge AccessibilityKnowledge ManagementProcess ReliabilityProduct Lifecycle

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