Process analytical technology

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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