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Information
on the Spring Process Analytical Technology
(PAT) Implementation Course 
The mission of the Duquesne University
Center for Pharmaceutical Technology (DCPT) is the
advancement of pharmaceutical manufacturing through
the application of appropriate technologies for
the improvement of safety, quality and efficiency
throughout the pharmaceutical industry. |
| DCPT exists as a focal point
for the research interests of faculty and collaborators
for the development and scientifically based implementation
of pharmaceutical manufacturing technology. It addresses
the major issues of regulatory concerns, science
based methods validation, and business advantages
of technology. Participants (clients and collaborators)
in the center include representatives from industry,
other academic institutions, regulatory authorities,
equipment vendors and private consultants. |
| Current Regulatory
Climate for the Pharmaceutical Industry |
Current Regulatory Climate for
the Pharmaceutical Industry
The current regulatory environment established by
the FDA is presenting the pharmaceutical industry
new opportunities to fundamentally change manufacturing
practices. Recent initiatives have explicitly called
for the implementation of process analytical technology
(or PAT).
|
| Process Analytical Technology
or PAT, a scientific, risk-based framework, should
help manufacturers develop and implement new efficient
tools for use during pharmaceutical development,
manufacturing, and quality assurance while maintaining
or improving the current level of product quality
assurance. The framework has two components: (1)
a set of scientific principles and tools supporting
innovation and (2) a strategy for regulatory implementation
that will accommodate innovation. PAT is considered
to be a system for designing, analyzing, and controlling
manufacturing through timely measurements (i.e.,
during processing) of critical quality and performance
attributes of raw and in-process materials and processes
with the goal of ensuring final product quality.
The goal of PAT is to understand and control the
manufacturing process, which is consistent with
current drug quality system: quality cannot
be tested into products; it should be built-in or
should be by design. This knowledge base can be
helpful to support and justify flexible regulatory
paths for innovations in manufacturing and post-approval
changes. |
| FDA encourages manufacturers
to use the PAT framework to develop and implement
new pharmaceutical manufacturing and quality assurance.
|
| The importance of these moves
by the FDA cannot be overstated. |
