A Case Study in Application of the Risk Knowledge Infinity Cycle

The Risk Knowledge Infinity (RKI) Cycle Framework was featured as part of the ICH-sanctioned training materials supporting the recent issuance of ICH Q9(R1) To support ICH Q9(R1) understanding and adoption, this paper presents a case study on the application of the RKI Cycle, based on an underlying...

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Bibliographic Details
Published inPDA journal of pharmaceutical science and technology Vol. 78; no. 3; p. 367
Main Authors Schmidt, Peer, Lipa, Martin J, Fogle, Jace, Baker, Owen, Pawlak, Timothy, McEwen, Sean, O'Donnell, Kevin
Format Journal Article
LanguageEnglish
Published United States 28.06.2024
Subjects
Drug Industry - methods
Humans
Knowledge Management
Quality Control
Risk Management - methods
Quality risk management
RKI Cycle
ICH Q9(R1)
Knowledge management
Pharmaceutical quality system
Risk-based decision-making
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Summary:The Risk Knowledge Infinity (RKI) Cycle Framework was featured as part of the ICH-sanctioned training materials supporting the recent issuance of ICH Q9(R1) To support ICH Q9(R1) understanding and adoption, this paper presents a case study on the application of the RKI Cycle, based on an underlying out-of-specification investigation. This case study provides a stepwise walk-through of the cycle to illustrate how key concepts within the ICH Q9(R1) revision can be achieved through better connecting quality risk management and knowledge management with a framework such as the RKI Cycle.
ISSN:1948-2124
DOI:10.5731/pdajpst.2023.012931