|
Introduction to QbD and its Application in Diverse Terrains
|
|
| Author:
|
DIVYA BISHT, SAMINATHAN J
|
| Abstract:
|
The assurance of quality, safety, and effectiveness of a product has dependably been essential from the customer and regulatory perspectives. QbD (quality by design) was an ideal approach to ensure quality products before US FDA (United States Food and Drug Administration) propelled cGMP (Current Good Manufacturing Practice) in 2002 and afterward ICH Q8 (pharmaceutical product development), Q9 (quality risk management) and Q10 (pharmaceutical quality system) guidelines were published exclusively emphasize QbD to ensure that the product quality should be built in by design. QbD as of late been expanding its domain at a winged pace getting across differing territories. In this paper, the basic knowledge of QbD, the elements (QTPP, CQA’s, CMA’s, CPP’s) of QbD, tools for QbD implementation, including risk assessment, Design of experiment (DOE), and Process Analytical Technology (PAT), are outlined brie?y. Moreover, the concrete applications of QbD in various industries are summarized and presented
|
| Keyword:
|
Control strategy, Elements, Design of Experiments (DOE), Process Analytical Technology (PAT), Quality by Design (QbD), Quality Risk Management (QRM).
|
| EOI:
|
-
|
| DOI:
|
-
|
| Download:
|
Request For Article
|
|
|