![Open Access](https://i-scholar.in/lib/pkp/templates/images/icons/fulltextgreen.png)
![Restricted Access](https://i-scholar.in/lib/pkp/templates/images/icons/fulltextred.png)
Real Time Release Testing-A Review
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.
User
Font Size
Information
- 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.
- FDA, Regulatory Perspective on Real Time Release Testing – American Association of Pharmaceutical Scientists Meeting, (Washington, DC) October 2011
- Angie Drakulich., Real Time Release Testing, Pharmaceutical Technology, 35, 2011, 42–49.
- Real Time Release Testing - PAT seminar
- FDA, Regulatory Perspective on Real Time Release Testing – American Association of Pharmaceutical Scientists Meeting, (Washington, DC) October 2011.
- Dasu. M, Naresh. R. Real Time Release Testing-A New Paradigm For Pharmaceutical Development. International Journal Of Pharmaceutical Sciences Review & Research, Mar/Apr 2013, Vol.19 Issue 2, p80
- 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)
![](https://i-scholar.in/public/site/images/abstractview.png)
Abstract Views: 210
![](https://i-scholar.in/public/site/images/pdfview.png)
PDF Views: 86