Process anaytical technology

1. • PRESENTD BY :-
• PATIL PRANJAY SADASHIV.
• FIRST YEAR M.PHARM.
• DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur
Process anaytical technology (pat)

2. Contents-
2
Introduction
Works
Types of implementation
Applications
Advantages & Disadvantages
PATregulatory approach
References

3. What is
PAT ????
3
“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.”

4. Principal of
pat….
4
Quality cannot be tested
into final product; it should
be built- in, or should be by
design.

5. what is the goal
of PAT??
5
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.

6. How PAT works??
Selection of Process
Selection of suitable PATsystem.
Identification of CPP (critical process p) Design Proc
On-line Test In-line Test
6

7. Types of PAT
Implementation
7
Initial phase- Process Optimization
Scale-up phase- Comparing data
Temporary process- gaining process info. &
understanding process.
Permanent process- Actual process monitoring &
control.

8. Why PAT Analysis is better than Lab. Analysis ??
8
Control environment-
Speed-
Operator error-
Safety-
Sample integrity-

9. Applications
9
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

10. Profile of a Process Analytical
Scientist-
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 Technical-
 Interpersonal effectiveness-
 Initiative-
 Business focus-
 Innovative-
 Learning
Overall leadership-

11. Advantages
11
Reduction in production cycletime-
Preventing reprocessing & rejection-
Increase automation-
Improve operatorsafety-
Reduce human error-
Improving energy & material use & increase capacity-
Continuous process-
Controlling variability-
Continuous improvement & knowledge management-

12. Disadvantages
12
Require efforts during design-
Implementation & maintenance stages is high-
Require specialized, expertise person-
Costly-

13. PAT regulatory
approach
13
PATcan be implemented under CGMP
inspections by PATteam or PATcertified
investigator .
A supplement can be submitted to the agency.
A protocol can be submitted to theagency.
After approval of protocol by agency then
manufacturer may request to a FDA PAT team for
inspection of preoperational review of a PAT
implementation.

14. PAT regulatory guidance
14
Regulatory agencies like US-FDA, ICH, ASTM etc.
who has been active in the area of PATin the
development of standards for use of PATin
pharmaceutical industry internationally in their
standards committee E55.
US-FDA was published PAT final guidance in SEP
2004

15. REFERENCES
15
www.google.co.in
www.dir-technologies.com
www.wikipedia.org
FDA’s PATweb page
www.fda.gov./cder/ops/PAT.htm

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