Process Analytical Technology is used to describe optimal applications of process analytical chemistry tools, feedback process control strategies, information management tools and process / product optimization strategies to the manufacture of pharmaceuticals.

1. M. Pharm Sem -II Presentation
FDA INITIATIVE ON PROCESS ANALYTICAL
TECHNOLOGY
SUBMITTED TO
SAVITRIBAI PHULE, PUNE UNIVERSITY , PUNE
FOR
PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF
MASTER OF PHARMACY
IN THE SUBJECT
Pharmaceutical Manufacturing Technology
IN THE FACULTY OF SCIENCE AND TECHNOLOGY
Bhujbal Knowledge City,
MET’s Institute of Pharmacy,
Adgaon, Nashik, 422003.
Maharashtra, India
Academic Year- 2020-2021 1
Presented By-
Vaishali Ganesh Mundhe
(Roll no. 08)
Guided By:
Dr. S.P.Ahirrao Mam

2. Content
Process Analytical Technology
PAT Tools
1. Multivariate Tools for Design, Data
Acquisition & Analysis
2. Process Analyzers
3. Process Control Tools
4. Continuous Improvement and Knowledge
Management Tools
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3. Process Analytical Technology
• The term “PAT” is used here to describe
optimal applications of process analytical
chemistry tools, feedback process control
strategies, information management tools &
product/process optimization strategies,
information management tools &
product/process optimization strategies to the
manufacture of pharmaceuticals.
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4. • A platform for Continuous Process Verification
(or Validation) and QA.
A. An Manufacturing / QA Perspective
B. An Regulatory Perspective
PAT TOOLS
• There are many tools available that enable
process understanding for scientific, risk-
managed pharmaceutical development,
manufacture & quality assurance.
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5. In the PAT framework, these tools can be
categorized according to the following:
1. Multivariate tools for design, data acquisition
& analysis.
2. Process analyzers
3. Process Control Tools
4. Continuous improvement & knowledge
management tools.
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6. 1. Multivariate Tools for Design, Data
Acquisition & Analysis
• A knowledge base can be of most benefit when
it consists of scientific understanding of the
relevant multi-factorial relationships as well as a
means to evaluate the applicability of this
knowledge in scenarios.
• This benefit can be achieved through the use of
multivariate mathematical approaches, such as
statistical design of experiments, response
surface methodologies, process simulation &
pattern recognition tools, in conjunction with
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7. knowledge management systems.
• Experiments conducted during product &
process development can serve as building
blocks of knowledge that grow to
accommodate a higher degree of complexity
throughout the life of product.
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8. 2. Process Analyzers
• Process analysis has advanced significantly
during the past several decades, due to an
increasing appreciation for the value of
collecting process data.
• Industrial drivers of productivity, quality &
environmental impact have supported major
advancements in this area.
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9. • Indeed some process analyzers provide non-
destructive measurements that contain
information related to biological, physical, &
chemical attributes of the materials being
processed.
• These measurements can be:
A] At-line
• Measurement where the sample is removed,
isolated from,& analyzed in close proximity to
the process stream.
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10. B] On-line
• Measurement where the sample is diverted
from the manufacturing process & may be
returned to the process stream.
C] In-line
• Measurement where the sample is not removed
from the process stream & can be invasive or
non-invasive. Process analyzers typically
generate large volumes of data.
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11. • Measurements collected from these process
analyzers need not be absolute values of the
attribute of interest.
• Design & construction of the process
equipment, the analyzer, & their interfaces are
critical to ensure that collected data are
relevant & representative of process & product
attributes.
• Robust design, reliability, & ease of operation
are important considerations.
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12. • Installation of process analyzers on existing
process equipment in production should be
done after risk analysis to ensure this
installation does not adversely affect process
or product quality.
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13. 3. Process Control Tools
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