A Case Study in Application of the Risk Knowledge Infinity Cycle

Peer Schmidt; Martin J Lipa; Jace Fogle; Owen Baker; Timothy Pawlak; Sean McEwen; Kevin O'Donnell

doi:10.5731/pdajpst.2023.012931

A Case Study in Application of the Risk Knowledge Infinity Cycle

PDA J Pharm Sci Technol. 2024 Jun 28;78(3):367-383. doi: 10.5731/pdajpst.2023.012931.

Authors

Peer Schmidt¹, Martin J Lipa², Jace Fogle¹, Owen Baker¹, Timothy Pawlak¹, Sean McEwen¹, Kevin O'Donnell³

Affiliations

¹ AbbVie.
² TU Dublin & Pharmaceutical Regulatory Science Team (PRST); and [email protected].
³ Health Products Regulatory Authority (HPRA).

PMID: 38942476
DOI: 10.5731/pdajpst.2023.012931

Abstract

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) Quality Risk Management 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.

Keywords: ICH Q9(R1); Knowledge management; Pharmaceutical quality system; Quality risk management; RKI Cycle; Risk-based decision-making.

MeSH terms

Drug Industry / methods
Humans
Knowledge Management
Quality Control
Risk Management* / methods