www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2024 BioPharm International
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I
n 2020, the International Council for Harmonisa-
tion (ICH) published a concept paper (1) that out-
lined a limited revision to the published guide-
line ICH Q9 Quality Risk Management (QRM) (2)
to address the fact that "the benefits of QRM [quality
risk management], as envisaged by ICH Q9, have not
yet been fully realized."
Arguably, despite the publication of the companion
ICH guidelines in the first decade of the 21st century,
ICH Q9 (2) and ICH Q10 Pharmaceutical Quality Sys-
tem (PQS) (3), there are still numerous challenges in
enhancing manufacturing operations, which lead to
quality issues and drug shortages. Even with signif-
icant efforts in QRM by both the industry and regu-
lators, there are signs that unmitigated risks persist
within the pharmaceutical industr y, resulting in
quality defects as reported by Kevin O'Donnell, Mar-
ket Compliance Manager at the Health Products Reg-
ulatory Authority (HPRA) in Ireland, who observed
that the number of total quality defects reported to
the Irish regulator between 2002 and 2021 had in-
creased by more than 10-fold (4). In addition, a sur-
vey of chief quality officers of 30 global pharmaceu-
tical companies found that the benefits envisioned
by ICH Q10 have generally not been realized, and in
some cases the situation was slightly worse or more
complex (5).
FDA's 2019 Drug Shortage Report underscored the
ongoing problem of dr ug shor tages in the United
States, suggesting manufacturers might prioritize
cost reduction over quality investment because qual-
ity is not viewed as a competitive marketplace advan-
tage (6). Concurrently, the US Senate Committee on
Homeland Security drew attention to the escalating
trend of essential medication shortages, impacting a
Shining a Light on the Long
Shadow of Subjectivity in
Quality Risk Management
Amin Ziaie,
QRM Merck & Co., Inc, PRST;
Anne Greene is director
PRST; and Marty Lipa, PhD,
PRST, all at the Technological
University Dublin.
This article explores the emergence of subjectivity in ICH Q9 (R1).
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Editor's Note:
This article was previously published in Pharmaceutical
Technology®'s March 2024 issue and was peer reviewed by a
member of PharmTech's Editorial Advisory Board.
