APR Sept/Oct 2023 - 104

MANUFACTURING
Leveraging Analytical Technology
Process for CMC
Erika Porcelli
Regulatory Services
Regulatory Compliance Associates®
Introduction
In the evolving field of pharmaceutical development, the implementation of Process
Analytical Technology (PAT) for manufacturing is an essential competitive advantage. PAT
offers widely accepted methods to safeguard quality assurance and the general safety of
pharmaceutical products. The goal of this article is to provide a summary of PAT, best practices
of principles and adoption of PAT, and how to leverage increased process knowledge in your
regulatory submission.
Understanding Process Analytical Technology (PAT)
Efficient pharmaceutical manufacturing is a significant facet of the global healthcare system.
The well-being of patients is contingent on the accessibility of safe and effective treatments.
The U.S. Food and Drug Administration (FDA) framework1
for process analytical technology
was originally established based on insights to facilitate quality improvement. It includes
risk-based regulatory outcomes that have been validated by both life science manufacturers
and FDA regulators.
The Agency framework is based on two primary drivers:
* Scientific principles and tools that support the development of innovation
* Regulatory strategies that accommodate innovation during the submission process
As Vice President of Regulatory
Services for Regulatory
Compliance Associates®
(RCA), Erika Porcelli touches
all aspects of the customer experience. RCA
provides consulting services to life science
organizations for resolution of compliance
and regulatory challenges. RCA is a global
business unit of Sotera Health, a trusted
partner to more than 5,800 customers in
over 50 countries, including 40 of the top 50
medical device companies and 8 of the top 10
pharmaceutical companies.
Principles of PAT
CMC (Chemistry, Manufacturing, and Controls) is one of the most influential facets of drug
product development. Traditional drug development in pharmaceutical manufacturing is
completed using batch processing and production sample lab testing to evaluate quality. This
approach has been effective in delivering quality pharmaceuticals to patients in need.
However, modern technologies now offer life science employees the opportunity for improving
pharmaceutical development. Specifically, PAT principles and technologies focus on increasing
quality assurance during the product development process. This often involves the use of
unique quality controls from different types of technologies.
PAT and CMC
The implementation of process analytical technology encourages drug manufacturers to
create a team-based regulatory approach to chemistry, manufacturing and controls. Further,
the review of current good manufacturing practices (cGMP) is also essential to the success of
process analytical technology.
Finally, in-depth CMC training is important to achieve certification in process analytical technology.
This is important considering the regulatory inspection review by Agency auditors for each new
drug in development. The ability to demonstrate regulatory compliance is a foundational training
strategy that supports the use of process analytical technology in manufacturing.
104
American Pharmaceutical Review | September/October 2023

APR Sept/Oct 2023

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