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A Case Study in Application of the Risk Knowledge Infinity Cycle.

Peer Schmidt1, Martin J Lipa2, Jace Fogle1

  • 1AbbVie.

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|June 28, 2024
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Summary

The Risk Knowledge Infinity (RKI) Cycle Framework aids understanding of ICH Q9(R1) Quality Risk Management. This case study shows how RKI connects risk and knowledge management for better compliance.

Keywords:
ICH Q9(R1)Knowledge managementPharmaceutical quality systemQuality risk managementRKI CycleRisk-based decision-making

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Area of Science:

  • Pharmaceutical Quality Risk Management
  • Knowledge Management Systems

Background:

  • ICH Q9(R1) Quality Risk Management guidelines have been recently updated.
  • Effective implementation requires robust frameworks connecting risk and knowledge management.
  • The Risk Knowledge Infinity (RKI) Cycle Framework is a key component of ICH-sanctioned training.

Purpose of the Study:

  • To present a case study demonstrating the application of the RKI Cycle Framework.
  • To illustrate how the RKI Cycle supports the understanding and adoption of ICH Q9(R1).
  • To show the practical connection between quality risk management and knowledge management.

Main Methods:

  • A case study approach was employed, focusing on an out-of-specification investigation.
  • A stepwise walk-through of the RKI Cycle was conducted.
  • The application illustrated key concepts from the ICH Q9(R1) revision.

Main Results:

  • The case study successfully demonstrated the RKI Cycle's utility in a real-world scenario.
  • The RKI Cycle effectively links quality risk management activities with knowledge management processes.
  • Application of the framework facilitated a deeper understanding of ICH Q9(R1) principles.

Conclusions:

  • The RKI Cycle Framework is a valuable tool for implementing ICH Q9(R1) Quality Risk Management.
  • Integrating risk and knowledge management via the RKI Cycle enhances compliance and operational efficiency.
  • This framework supports continuous improvement in pharmaceutical quality systems.