LSHC Horizons Brochure 2024 - Flipbook - Page 34
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Clinical Trials
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FDA inspections of drug manufacturing and bioresearch monitoring
facilities: Expect heightened vigilance in 2024
FDA inspections play a pivotal role in
identifying and rectifying potential issues that
could compromise the safety of drugs, the
reliability of research findings, and the rights
and welfare of clinical trial participants. In
2024, FDA is likely to intensify its focus on
whether drug manufacturing and bioresearch
facilities are adhering to Current Good
Manufacturing Practices (CGMP) and Good
Clinical Practices (GCP), respectively.
FDA takes a risk-based approach that involves
the weighing of several factors in determining
whether to inspect a given facility. For
example, facilities involved in an application
for a new molecular entity or those involved
in a sponsor’s first marketing application are
top candidates for inspections. During the
COVID-19 pandemic, FDA relied heavily on
remote interactive evaluation tools to evaluate
drug and device manufacturing facilities and
has stated that it will continue to do. Although
a remote evaluation does not constitute an
inspection under the federal Food, Drug, and
Cosmetic Act (FDCA), it gives FDA greater
insight into a facility’s operations and issues
that may warrant an on-site inspection.
Relatedly, the number of foreign and domestic
inspections conducted has steadily increased
since 2020. Additionally, in 2023, the U.S.
Congress granted FDA greater authority to
inspect a wider range of parties involved in
clinical research and development activities,
such as consultants and vendors, and records
Robert F. Church
Partner
Los Angeles
related to studies and FDA submissions. FDA
also submitted a legislative proposal for the
2024 fiscal year requesting that Congress
expand FDA’s capabilities under the FDCA
to conduct inspections of establishments
manufacturing non-application finished dosage
forms, active pharmaceutical ingredients and
sterile drug substances.
For drug manufacturing and bioresearch
facilities, these trends serve as a reminder to
prioritize CGMP and GCP compliance, invest
in robust quality management systems, and
foster a culture of continuous improvement.
Manufacturing establishments should pay
particular attention to process validation
procedures and records, the adequacy of
written production procedures, and records
evidencing the investigation and review of
batch discrepancies. Key GCP areas, including
study monitoring, informed consent practices,
and maintenance of adequate case history and
study records, should also be addressed.
Establishing a proactive approach to identifying
and addressing potential compliance gaps is
essential. If you have any questions about this
article, please contact one of the authors or the
Hogan Lovells attorney with whom you work.
Heidi Forster Gertner
Partner
Washington, D.C.
Stephanie Agu
Senior Associate
Miami
