hello frnds....my presentation gives the information about process analytical technology...

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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