Opportunities for improvement in managing pre-PPQ biologic product knowledge

Beth Fulton; Theo Zacharatos; Igor Gorsky; Angelica Welch; James Vesper

doi:10.5731/pdajpst.2024-003032.1

Abstract

Knowledge management (KM) is vital for supporting product quality throughout a biologic drug product's lifecycle. This paper presents suggestions for management of pre-PPQ (Process Performance Qualification) knowledge management for biologic manufacturing organizations. This topic was presented at the 2024 PDA Annual conference, with subjective audience survey questions that were employed in real time to customize the talking points for the presentation of KM suggestions.

This paper presents a lifecycle knowledge management concept called the CQA (Critical Quality Attribute) Knowledge Accessibility Maintenance Loop (CQA-KAML). This lifecycle has been created to help organizations effectively find and manage CQA-relevant knowledge starting in the pre-PPQ phase of biologic product development to align with ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) Q10 and other regulatory guidances.

Received November 21, 2024.
Revision received September 22, 2025.
Revision received July 11, 2025.
Accepted October 6, 2025.

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