Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 37
mal Drug and Biologics Manufacturing Operations
During the COVID-19 Public Health Emergency (7),
provided guidance on how to prioritize GMP ac-
tivities, and how to evaluate the impact on GMP
processes. Many manufacturers, including Catal-
ent, were affected, and the guidance was helpful
in obtaining FDA's current thinking on the GMP
impact assessment. Using our quality management
system and established processes for risk manage-
ment, Catalent has been able to avoid any poten-
tial delays incurred by using innovative systems,
such as conditional releases, reduced testing, and
quality holds. These allowed forward processing
to be undertaken at risk, while having controls in
place to regulate the release of finished product to
market. Additionally, we employed remote audits
of suppliers and service providers in our efforts to
prioritize the manufacture of product for patients.
Lessons learned
PharmTech: Has the fast tracking of authorizations
for COVID-19 vaccines impacted sterile and bio-
logics manufacturing? What lessons have been
learned?
Davis-Claeys (Catalent Bloomington): The authori-
zation fast tracking has led to adjustments being
made at manufacturing sites. Development, man-
ufacturing, and validation activities are typically
performed in a step-wise fashion; however, the
EUA applications have required manufacturers to
perform activities in parallel, and implement con-
trols or stage gates to ensure all documentation is
in place prior to release to market. In this situation,
a strong change control and quality management
system is needed in order to be successful.
COVID-19 also demonstrated that teamwork
and communication can occur between industry
and FDA to ensure that a safe and effective product
is delivered to patients in a timely manner.
Heidaran (Parexel Consulting): A shortage of com-
ponents for manufacturing has been experienced
and full compliance oversight has been impeded
due to many factors including travel restrictions,
etc. As a result, the industry has experienced short-
ages requiring changes of components at a time
when reporting categories may have become over-
burdensome. In some cases, changes were imple-
mented to meet market demand without following
the reporting requirements. FDA has recognized
this and by publishing guidance documents is at-
tempting to provide guidance on how to expedite
the reporting or to become fully compliant using
existing available tools. By and large, the indus-
try has been successful in managing unexpected
changes to manufacturing, but this experience un-
derscores the importance of organizational readi-
ness to manage change efficiently.
References
1. FDA, Remote Interactive Evaluations of Drug Manufacturing
and Bioresearch Monitoring Facilities During the COVID-19
Public Health Emergency, Guidance for Industry (FDA, April
2021).
2. FDA, COVID-19 Container Closure System and Component
Changes: Glass Vials and Stoppers, Guidance for Industry
(CDER, CBER March 2021).
3. FDA, Manufacturing Considerations for Licensed and Investiga-
tional Cellular and Gene Therapy Products During COVID-19
Public Health Emergency, Guidance for Industry (CBER, Janu-
ary 2021).
4. FDA, Emergency Use Authorization of Medical Products and
Related Authorities, Guidance for Industry and Other Stake-
holders (FDA, January 2017).
5. ICH, Q12 Technical and Regulatory Considerations for Pharma-
ceutical Product Lifecycle Management (ICH, March 4, 2020).
6. M. Heidaran et al., "Impact of COVID-19 on Manufacturing of
Cell and Gene Therapy and Biotech Products, and Overall
Clinical Trial Landscape," American Pharmaceutical Review -
The Review of American Pharmaceutical Business & Technology,
Aug. 28, 2020.
7. FDA, Resuming Normal Drug and Biologics Manufacturing
Operations During the COVID-19 Public Health Emergency
Guidance for Industry (FDA, September 2020).
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