N. R. Gayathri Devi *, 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.
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- Strategic Control https://en.wikipedia.org/wiki/ Strategic_control(2017)
- Critical Quality Attributes https://en.wikipedia.org/wiki/Critical_quality_attributes(2017)
