LSHC Horizons Brochure 2024 - Flipbook - Page 11
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | ESG and Supply Chain
A business case for Quality Management Maturity
Quality Management Maturity (QMM) is
achieved by implementing quality management
practices that go above and beyond minimum
current good manufacturing practice
(CGMP) requirements to manage continuous
improvement, resulting in sustainable
compliance, reliable supply chains, and
confidence for patients in the availability of their
medicines. Investments by drug manufacturers
in mature quality management practices mitigate
the likelihood of issues associated with poor
drug quality and can lead to higher operational
performance, improved relationships with
regulators and customers, and higher revenues.
FDA first proposed a QMM program in
2019, when an interagency task force called
for a system to measure and rate the QMM
of drug manufacturing facilities to address
drug shortages. A major challenge has been
convincing the pharmaceutical industry how
the program would alleviate drug shortages,
especially when there are no clear regulatory
incentives. In the past 18 months, FDA appears
to have ramped up efforts to develop a QMM
program, including running pilot programs,
publishing multiple white papers, convening an
advisory committee workshop, and soliciting
comments from industry. Although these efforts
suggest that FDA is preparing more seriously to
launch a formal QMM program, the exact timing
and components of the program remain unclear.
What is more clear are key revisions to FDA’s
compliance programs for drug manufacturing
inspections, which appear to align with
underlying QMM principles requiring a holistic
approach to quality and compliance.
Lowell M. Zeta
Partner
Washington, D.C.
For example, FDA investigators are instructed
during pre-approval or pre-licensure
inspections to gather data in support the firm’s
commitment to quality in pharmaceutical
development. Additionally, the agency
updated its drug manufacturing inspection
program to include an assessment of quality
management practices to gain insight into
continual system improvements. FDA has
increasingly cited firms during inspection for
ineffective quality systems, specifically requiring
a comprehensive assessment of the company’s
global manufacturing operations and support
from executive leadership to proactively address
emerging issues and to assure a continuing state
of control.
While FDA’s formal QMM program currently
remains a moonshot idea, the agency’s revised
compliance policies may suggest a higher
threshold standard for drug manufacturers’
quality programs. An increasing focus on
proactive and continuous improvement is
critical for drug manufacturers to keep pace
with or ahead of FDA’s expectations, and
manufacturers should continually assess the
potential impact of both major changes
(e.g., organizational transformations, strategic
acquisitions) and routine quality events
(e.g., investigations, FDA inspections) on
their state of control. We routinely monitor for
developments in this area as we continue to
counsel clients on complex quality remediation
efforts, strategic quality maturity assessments,
and sustainable CGMP compliance.
Sally Gu
Senior Associate
Washington, D.C.
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