Quality Management System (QMS)

PE Magazine
ISPE held an Expert Xchange on 18 January 2022 that included presentations and interactive exercises that generated new and useful insights into the current effectiveness of the knowledge that flows into QRM and how a knowledge map can be used to diagnose opportunities to improve KM. The exercises also helped identify the types of knowledge generated during QRM. These insights demonstrated the opportunity to improve risk-based decision-making by uniting risk and knowledge through a suitable framework such as the Risk-Knowledge Infinity (RKI) Cycle.
Guidance Docs
Health authorities and regulators are increasingly looking for much higher levels of traceability during the manufacture of parenteral medicines. The...