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hello frnds....my presentation gives the information about process analytical technology...
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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)
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Contents-IntroductionWorks Types of implementationApplications Advantages & DisadvantagesPAT regulatory approachReferences
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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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Principal of pat….
Quality cannot be tested into final product; it should be built- in, or should be by design.
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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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How PAT 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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Types of PAT Implementation
Initial phase- Process OptimizationScale-up phase- Comparing dataTemporary process- gaining process info. &
understanding process.Permanent process- Actual process monitoring &
control.
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Why PAT Analysis is better than Lab. Analysis ??
Control environment-Speed-Operator error-Safety-Sample integrity-
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ApplicationsProcess 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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Profile of a Process Analytical Scientist-
Technical- Interpersonal effectiveness- Initiative- Business focus- Innovative- LearningOverall leadership-
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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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Disadvantages
Require efforts during design-Implementation & maintenance stages is
high-Require specialized, expertise person-Costly-
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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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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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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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