1.
PDA J Pharm Sci Technol
; 78(3): 367-383, 2024 Jun 28.
Artículo
en Inglés
| MEDLINE
| ID: mdl-38942476
RESUMEN
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.