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Real Time Release Testing-A Review


Affiliations
1 Department of Quaity Assurance, Krupanidhi College of Pharmacy Bangalore, Karnataka, India
 

QbD is a systemic approach to attain a intended product quality, the tools which assist the QbD principle are design space and Process Analytical Technology(PAT).Now Modern application called Real Time Release Testing has came in to existence which can be accompanied with or without design space and PAT tools. Real time release testing is set of In-process controls that provide greater assurance of product quality than end - product testing under specific conditions. RTRT involves at-line and on-line measurements of critical quality attributes for eg., (tablet weight after compression, moisture measurement during drying, blend uniformity)where they are generated to ensure the product quality in real time. This real time release testing challenge is to perform the right measurement at right time and at the right location. RTRT improves and enhances analytical testing without affecting either product quality or manufacturing cycle.

Keywords

Real Time Release Testing, PAT, End-Product Testing.
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  • Real Time Release Testing http://www.industry. siemens.com/verticals/global/Documents/pateventslides/4_real-time-release-testing.pdf (2010)
  • Parametric Release-European Commission http:// www.emea.eu-int/htms/human/qwp/qwpfinhtm( 2001)
  • EMA, “Guideline on real time release testing (formerly Guideline on parametric release)” March 2012.
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  • Real Time Release Testing for Beginners www.slideshare.net/shettyuc/real-time-releasetestingfor-beginners(2012)
  • pharmaceutical “Quality By Design”(QbD):An Introduction,Process Development & Applications http://learnaboutgmp.com/pharmaceuticalqualityby-design-qbd-an-introduction-processdevelopmentand-applications/
  • Process Analytical Technology https://en.wikipedia.org/wiki/Process_analytical_technology (2016)
  • Strategic Control https://en.wikipedia.org/wiki/ Strategic_control(2017)
  • Critical Quality Attributes https://en.wikipedia.org/wiki/Critical_quality_attributes(2017)

Abstract Views: 210

PDF Views: 86




  • Real Time Release Testing-A Review

Abstract Views: 210  |  PDF Views: 86

Authors

N. R. Gayathri Devi
Department of Quaity Assurance, Krupanidhi College of Pharmacy Bangalore, Karnataka, India
R. Chandramouli
Department of Quaity Assurance, Krupanidhi College of Pharmacy Bangalore, Karnataka, India

Abstract


QbD is a systemic approach to attain a intended product quality, the tools which assist the QbD principle are design space and Process Analytical Technology(PAT).Now Modern application called Real Time Release Testing has came in to existence which can be accompanied with or without design space and PAT tools. Real time release testing is set of In-process controls that provide greater assurance of product quality than end - product testing under specific conditions. RTRT involves at-line and on-line measurements of critical quality attributes for eg., (tablet weight after compression, moisture measurement during drying, blend uniformity)where they are generated to ensure the product quality in real time. This real time release testing challenge is to perform the right measurement at right time and at the right location. RTRT improves and enhances analytical testing without affecting either product quality or manufacturing cycle.

Keywords


Real Time Release Testing, PAT, End-Product Testing.

References