RT Journal Article
SR Electronic
T1 Applying Knowledge to Manage Risk - A Case Study in Application of the Risk Knowledge Infinity (RKI) Cycle
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2023.012931
DO 10.5731/pdajpst.2023.012931
A1 Schmidt, Peer
A1 Lipa, Martin J
A1 Fogle, Jace
A1 Baker, Owen
A1 Pawlak, Timothy
A1 McEwen, Sean
A1 O'Donnell, Kevin
YR 2024
UL http://journal.pda.org/content/early/2024/04/25/pdajpst.2023.012931.abstract
AB To support ICH Q9(R1) understanding and adoption, this paper presents a case study on the application of the RKI Cycle Framework, based on an underlying out of specification investigation. The RKI Cycle was featured as part of the ICH-sanctioned training materials supporting the recent issuance of ICH Q9(R1) Quality Risk Management. 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.