Developing an Optimized Risk Assessment Portfolio: The Quality Risk Management Master Plan.

RISK assessment; MEDICAL protocols; PLANNING techniques; PHARMACEUTICAL technology; OCCUPATIONAL roles; RISK management in business; LEADERSHIP; INTERNATIONAL agencies; DECISION making; PHARMACEUTICAL industry; MATERIALS management; QUALITY assurance; AUTOMATION; MANAGEMENT; MEDICAL equipment safety measures

The article focuses on the development of quality risk management (QRM) practices within the pharmaceutical and biopharmaceutical industry since 2009. Topics include the overwhelming volume of initial risk assessments performed, the challenges posed by excessive assessments, and the improved guidance provided by the ICH Q9(R1) for planning necessary risk assessments more effectively.