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.”

1. PROCESS ANALYTICAL
TECHNOLOGY ( PAT )
 PRESENTED BY MR.AMIT H.KANSE.
(M. PHARM ) RAJGAD DNYANPEETH COLLEGE OF
PHARMACY BHOR,PUNE.
 QUALITY ASSURANCE TECHNIQUES
2017-2018
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2. Contents
 Introduction
 Works
Types of implementation
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. PROCESS ANALYTICAL TECHNOLOGY (PAT)
 PAT includes:
 Timely measurements during processing
 Critical quality and performance attributes
 Raw and in-process materials
 At-line, on-line or in-line measurements founded on
“Process Understanding”
 Opportunities for improvement.
 More reliable and consistent processes (& product)
 Less failures, less reworks, less recalls
 Flexibility scale and equipment
 Better / faster Quality Systems.
 Process Enhancement Opportunities
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5. Principal of PAT ……..
Quality cannot be tested
into final product; it should
be built- in, or should be by
design.
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6. WHAT IS THE GOAL OF PAT??
A. Building quality into products.
B. To enhance understanding and
control the manufacturing
process.
C. The goal is to reduce variation
in our processes.
D. To enhance process safety.
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7. HOW PAT WORKS ??
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Selection of
Process
Identification of
CPP (critical
process p)
Design
Process
On-line TestIn-line Test

8. SUMMARY - TOOLS IN THE TOOLBOX
PAT is not just Analytical and not only NIR…...!!
 Raman
 Image/Vision
 Acoustics
 Fluorescence
 UV/Vis
 FBRM (Laser scattering)
 LIBS
In conjunction with….
 Process Engineering
 Multivariate Data Analysis
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9. 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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10. WHY PAT ANALYSIS IS BETTER THAN
LAB. ANALYSIS ??
1) Control environment.
2) Speed.
3) Operator error.
4) Safety.
5) Sample integrity.
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11. Profile of a Process Analytical Scientist
1) Technical
2) Interpersonal effectiveness
3) Initiative
4) Business focus
5) Innovative
6) Learning
7) Overall leadership
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12. ADVANTAGES
1) Reduction in production cycle time
2) Preventing reprocessing & rejection
3) Increase automation
4) Improve operator safety
5) Reduce human error
6) Improving energy & material use &
increase capacity
7) Continuous process
8) Controlling variability
9) Continuous improvement & knowledge
management
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13. DISADVANTAGES
1) Require efforts during design-
2) Implementation & maintenance
stages is high-
3) Require specialized, expertise
person-
4) Costly
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14. LONG-TERM GOALS OF PAT
1. Reduce production cycling time
2. Prevent rejection of batches
3. Enable real time release
4. Increase automation and
control
5. Improve energy and material
use
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15. 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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16. 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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17. REFERENCES
1. www.google.co.in
2. www.dir-technologies.com
3. www.wikipedia.org
4. FDA’s PAT web page
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