Quality Risk Management: State of the Industry—Part 1. Has the Industry Realized the Full Value of ICH Q9?
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This paper summarizes research designed to characterize the current state of pharmaceutical and biotechnology industries with respect to the adoption of Quality Risk Management as per ICH Q9. The research supports the hypotheses that the full value of QRM with respect to product quality and patient safety has not yet been realized. In addition, industry appears to be lagging behind regulatory expectations with respect to QRM maturity, indicating that current approaches to QRM require significant improvement.
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2020 ◽
Vol 11
(4)
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pp. 5407-5414
2013 ◽
Vol 11
(01)
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pp. 74-82
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2013 ◽
Vol 20
(4)
◽
pp. 218-222
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2016 ◽
Vol 79
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pp. S11-S18
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2019 ◽
Vol 73
(4)
◽
pp. 331-344
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