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Ashish Mukherjee IJCPS, 2014, Vol.2(7): 1015-1026

International Journal of Chemistry and Pharmaceutical Sciences 1015

ISSN: 2321-3132Review Article

International Journal of Chemistry andPharmaceutical Scienceswww.pharmaresearchlibrary.com/ijcps

A Review on Process Analytical Technology (PAT) & its Application

Dr. Ajoy Bera and Dr. Ashish Mukherjee

Central Drugs Laboratory, 3, Kyd Street, Kolkata 700 016Received: 18 April 2014, Accepted: 15 June 2014, Published Online: 27 July 2014

Contents1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10152. Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10163. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . 10254. Acknowledgement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . 10255. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1026

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Copyright 2014, IJCPS All Rights Reserved

1. IntroductionProcess analytical technology (PAT) is one of the objectives contained in the Initiative for Pharmaceutical cGMPsfor the 21st Century published by the Food and Drug Administration (FDA) to reduce the risk of making a poorproduct. With the help of PAT, pharmaceutical companies are now better equipped to increase process efficienciesand design quality product. With the goal of ensuring final product quality, it analyzes raw and in - processmaterials. PAT involves Measurement science by using conventional process sensors such as pressure, temperatureand pH, Probes, as well as novel analyzer technologies. According to the FDAs guideline, PAT can be defined as a

AbstractProcess Analytical Technologies (PAT) describes a system, which is for designing and controllingmanufacturing through timely measurements (i.e. during processing) of critical quality and performanceattributes for raw and in-process materials and also processes with the goal of ensuring final product quality. ThePAT initiative focuses on building quality into the product and manufacturing processes, as well as continuousprocess improvement. It is well known that pharmaceutical production involves the manufacture of the finishedproduct, followed by laboratory analysis to verify quality. The disadvantages associated with this approach arecontinual process optimization, recurring manufacturing difficulties, and the possibility of failed batches. Thisarticle provides an overview of Process Analytical Technology and its application to the pharmaceuticalindustry. It, however, is a wide-ranging subject, which is expanding rapidly. Effective PAT implementationcomprise of science-based understanding of the physical, chemical and mechanical properties of all elements ofthe proposed drug product. The overall PAT venture is promising for delivering an integrated systems approachfor quality design, process analysis, understanding and control, continuous improvement, knowledge and risk-based management. The incorporation of early PAT devices, increase process efficiency and safety by acting ondata in real time and by eliminating sampling. On the top of that PAT applications, increase detailed knowledgeof processes, leading to increased robustness and greater processing opportunities. Emphasis is placed onchemometrics, which is the use of mathematical and statistical models to extract and interpret chemical data.Keywords: Process Analytical Technology, ICHQ10, Process analyzers, cost control, chemometrics

*Corresponding authorAshish MukherjeeCentral Drugs Laboratory,3, Kyd Street, Kolkata 700 016Manuscript ID: IJCPS2211

Ashish Mukherjee IJCPS, 2014, Vol.2(7): 1015-1026

International Journal of Chemistry and Pharmaceutical Sciences 1015

ISSN: 2321-3132Review Article

International Journal of Chemistry andPharmaceutical Scienceswww.pharmaresearchlibrary.com/ijcps

A Review on Process Analytical Technology (PAT) & its Application

Dr. Ajoy Bera and Dr. Ashish Mukherjee

Central Drugs Laboratory, 3, Kyd Street, Kolkata 700 016Received: 18 April 2014, Accepted: 15 June 2014, Published Online: 27 July 2014

Contents1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10152. Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10163. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . 10254. Acknowledgement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . 10255. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1026

PAPER-QR CODE

Copyright 2014, IJCPS All Rights Reserved

1. IntroductionProcess analytical technology (PAT) is one of the objectives contained in the Initiative for Pharmaceutical cGMPsfor the 21st Century published by the Food and Drug Administration (FDA) to reduce the risk of making a poorproduct. With the help of PAT, pharmaceutical companies are now better equipped to increase process efficienciesand design quality product. With the goal of ensuring final product quality, it analyzes raw and in - processmaterials. PAT involves Measurement science by using conventional process sensors such as pressure, temperatureand pH, Probes, as well as novel analyzer technologies. According to the FDAs guideline, PAT can be defined as a

AbstractProcess Analytical Technologies (PAT) describes a system, which is for designing and controllingmanufacturing through timely measurements (i.e. during processing) of critical quality and performanceattributes for raw and in-process materials and also processes with the goal of ensuring final product quality. ThePAT initiative focuses on building quality into the product and manufacturing processes, as well as continuousprocess improvement. It is well known that pharmaceutical production involves the manufacture of the finishedproduct, followed by laboratory analysis to verify quality. The disadvantages associated with this approach arecontinual process optimization, recurring manufacturing difficulties, and the possibility of failed batches. Thisarticle provides an overview of Process Analytical Technology and its application to the pharmaceuticalindustry. It, however, is a wide-ranging subject, which is expanding rapidly. Effective PAT implementationcomprise of science-based understanding of the physical, chemical and mechanical properties of all elements ofthe proposed drug product. The overall PAT venture is promising for delivering an integrated systems approachfor quality design, process analysis, understanding and control, continuous improvement, knowledge and risk-based management. The incorporation of early PAT devices, increase process efficiency and safety by acting ondata in real time and by eliminating sampling. On the top of that PAT applications, increase detailed knowledgeof processes, leading to increased robustness and greater processing opportunities. Emphasis is placed onchemometrics, which is the use of mathematical and statistical models to extract and interpret chemical data.Keywords: Process Analytical Technology, ICHQ10, Process analyzers, cost control, chemometrics

*Corresponding authorAshish MukherjeeCentral Drugs Laboratory,3, Kyd Street, Kolkata 700 016Manuscript ID: IJCPS2211

Ashish Mukherjee IJCPS, 2014, Vol.2(7): 1015-1026

International Journal of Chemistry and Pharmaceutical Sciences 1015

ISSN: 2321-3132Review Article

International Journal of Chemistry andPharmaceutical Scienceswww.pharmaresearchlibrary.com/ijcps

A Review on Process Analytical Technology (PAT) & its Application

Dr. Ajoy Bera and Dr. Ashish Mukherjee

Central Drugs Laboratory, 3, Kyd Street, Kolkata 700 016Received: 18 April 2014, Accepted: 15 June 2014, Published Online: 27 July 2014

Contents1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10152. Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10163. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . 10254. Acknowledgement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . 10255. References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1026

PAPER-QR CODE

Copyright 2014, IJCPS All Rights Reserved

1. IntroductionProcess analytical technology (PAT) is one of the objectives contained in the Initiative for Pharmaceutical cGMPsfor the 21st Century published by the Food and Drug Administration (FDA) to reduce the risk of making a poorproduct. With the help of PAT, pharmaceutical companies are now better equipped to increase process efficienciesand de

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