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Related Concept Videos

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Related Experiment Video

Updated: Jan 14, 2026

Operating and Biocontainment Procedures of a Facility for Laboratory Mice with a Natural Microbiome: Immunophenotyping Procedure
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Opportunities for improvement in managing pre-PPQ biologic product knowledge.

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
Summary

Effective knowledge management (KM) is crucial for biologic drug quality. This paper introduces the CQA Knowledge Accessibility Maintenance Loop (CQA-KAML) for managing critical quality attribute knowledge before Process Performance Qualification (PPQ).

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

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Area of Science:

  • Pharmaceutical Manufacturing
  • Biologics Development
  • Knowledge Management Systems

Background:

  • Knowledge management (KM) is essential for maintaining biologic drug product quality throughout its lifecycle.
  • Effective KM strategies are needed, particularly in the pre-Process Performance Qualification (PPQ) phase.
  • Current practices may not adequately capture or leverage critical quality attribute (CQA) knowledge.

Purpose of the Study:

  • To propose a structured approach for knowledge management in biologic manufacturing organizations before PPQ.
  • To introduce the Critical Quality Attribute Knowledge Accessibility Maintenance Loop (CQA-KAML) concept.
  • To align KM practices with regulatory expectations, such as ICH Q10.

Main Methods:

  • The paper presents a conceptual framework for lifecycle knowledge management.
  • It incorporates insights from a presentation at the 2024 PDA Annual conference.
  • Real-time audience feedback was used to tailor KM suggestions.

Main Results:

  • A novel lifecycle knowledge management concept, CQA-KAML, is introduced.
  • This framework facilitates the identification and management of CQA-relevant knowledge.
  • The approach aims to enhance knowledge accessibility and retention from early development stages.

Conclusions:

  • Implementing the CQA-KAML can improve knowledge management for biologic drug development.
  • Proactive KM before PPQ is vital for ensuring product quality and regulatory compliance.
  • The CQA-KAML provides a systematic method to align with guidelines like ICH Q10.