PharmTech.com Regulating Innovation, Quality, and Risk eBook January 2024 Pharmaceutical Technology
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Peer-Reviewed
This article was peer-reviewed by a member of
Pharmaceutical Technology®'s Editorial Advisory Board:
Subitted: September 24, 2023
Accepted: October 5, 2023.
For more articles on the International Council for
Harmonisation's Q9 revision, see additional aritcles in
this ebook or visit PharmTech.com to read the following:
• The ICH Q9 Revision and a Renewed Focus on
Quality Risk Management Fundamentals
The ICH Q9 revision clarifies QRM implementation
for the pharmaceutical industry and expands
descriptions of methodology, formality, and risk-
based decision making to provide the industry
with a solid base from
which to build their own QRM programs.
https://www.pharmtech.com/view/the-ich-q9-
revision-and-a-renewed-focus-on-quality-risk-
management-fundamentals
• Navigating the Formality
Spectrum in ICH Q9(R1)
The degree of formality in a risk
management process should be customized
to the organization's particular needs and
the risks involved.
https://www.pharmtech.com/view/navigating-
the-formality-spectrum-in-ich-q9-r1-
