This document discusses Process Analytical Technology (PAT). It begins with an introduction to PAT, defining it as a system to design, analyze, and control manufacturing through timely measurements of critical quality attributes. It then discusses how PAT works by selecting a suitable PAT system and identifying critical process parameters. It highlights some key benefits of PAT such as improving process understanding and control, enhancing safety, and reducing variation. The document also provides examples of common PAT applications and discusses regulatory guidance around implementing PAT from agencies like the FDA.

1. PRESENTED BY
ANJALI BHARAT
(M. PHARM )
QAT, ROLL NO-01
2013-2014
P.D.V.V.P.F’S COLLEGE OF PHARMACY. AHMEDNAGAR.
Process anaytical technology (pat)

2. Contents-
 Introduction
 Works
 Types of implementation
 Applications
 Advantages & Disadvantages
 PAT regulatory approach
 References
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3. What is PAT????
“A system for designing, analyzing & controlling
manufacturing through timely measurements (i.e.
during processing) of critical quality & performance
attributes for raw & in-process materials & processes
with the goal of ensuring final product quality.”
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4. Principal of pat….
 Quality cannot be tested
into final product; it should
be built- in, or should be by
design.
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5. what is the goal of PAT??
 Building quality into products.
 To enhance understanding and control the
manufacturing process.
 The goal is to reduce variation in our processes.
 To enhance process safety.
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6. HowPAT works??
Selection of Process
Selection of suitable PAT system.
Identification of CPP (critical process p)
Design Process
On-line Test In-line Test
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7. Types of PAT Implementation
 Initial phase- Process Optimization
 Scale-up phase- Comparing data
 Temporary process- gaining process info. &
understanding process.
 Permanent process- Actual process monitoring &
control.
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8. Why PAT Analysis is better than Lab. Analysis ??
 Control environment-
 Speed-
 Operator error-
 Safety-
 Sample integrity-
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9. Applications
Process Steps PAT Tech. in-line, off-line Testing
Raw material, Dispensing NIR, Raman
Reaction monitoring Mid- IR, N-IR, UV-visible.
Crystallization Mid-IR, Raman
API drying N-IR
Wet granulation N-IR
Fluid bed drying N-IR
Blending N-IR, Raman
Lubrication N-IR
coating N-IR
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10. 10
Profileof a Process Analytical Scientist-
 Technical-
 Interpersonal effectiveness-
 Initiative-
 Business focus-
 Innovative-
 Learning
Overall leadership-

11. Advantages
 Reduction in production cycle time-
 Preventing reprocessing & rejection-
 Increase automation-
 Improve operator safety-
 Reduce human error-
 Improving energy & material use & increase capacity-
 Continuous process-
 Controlling variability-
 Continuous improvement & knowledge management-
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12. Disadvantages
 Require efforts during design-
 Implementation & maintenance stages is high-
 Require specialized, expertise person-
 Costly-
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13. PAT regulatory approach
 PAT can be implemented under CGMP
inspections by PAT team or PAT certified
investigator .
 A supplement can be submitted to the agency.
 A protocol can be submitted to the agency.
 After approval of protocol by agency then
manufacturer may request to a FDA PAT team for
inspection of preoperational review of a PAT
implementation.
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14. PAT regulatory guidance
 Regulatory agencies like US-FDA, ICH, ASTM etc.
who has been active in the area of PAT in the
development of standards for use of PAT in
pharmaceutical industry internationally in their
standards committee E55.
 US-FDA was published PAT final guidance in SEP
2004
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15. REFERENCES
 www.google.co.in
 www.dir-technologies.com
 www.wikipedia.org
 FDA’s PAT web page
 www.fda.gov./cder/ops/PAT.htm
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