RT Journal Article
SR Electronic
T1 2015/2016 Quality Risk Management Benchmarking Survey
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2017.007526
DO 10.5731/pdajpst.2017.007526
A1 Waldron, Kelly
A1 Ramnarine, Emma
A1 Hartman, Jeffrey
YR 2017
UL http://journal.pda.org/content/early/2017/05/15/pdajpst.2017.007526.abstract
AB This paper investigates the concept of Quality Risk Management (QRM) maturity as it applies to the pharmaceutical and biopharmaceutical industries, using the results and analysis from a QRM benchmarking survey conducted in 2015 and 2016. QRM maturity can be defined as the effectiveness and efficiency of a quality risk management program, moving beyond 'check-the-box' compliance with guidelines such as ICH Q9 Quality Risk Management, to explore the value QRM brings to business and quality operations. While significant progress has been made towards full adoption of quality risk management principles and practices across industry, the full benefits of QRM have not yet been fully realized. The results of the QRM Benchmarking Survey indicate that the pharmaceutical and biopharmaceutical industries are approximately halfway along the journey towards full QRM maturity.