Quality by Design in Action 1: Controlling Critical Quality Attributes of an Active Pharmaceutical Ingredient

Volume: 19, Issue: 11, Pages: 1634 - 1644
Published: Feb 10, 2015
Abstract
The importance of Quality by Design (QbD) is being realized gradually, as it is gaining popularity among the generic companies. However, the major hurdle faced by these industries is the lack of common guidelines or format for performing a risk-based assessment of the manufacturing process. This article tries to highlight a possible sequential pathway for performing QbD with the help of a case study. The main focus of this article is on the...
Paper Details
Title
Quality by Design in Action 1: Controlling Critical Quality Attributes of an Active Pharmaceutical Ingredient
Published Date
Feb 10, 2015
Volume
19
Issue
11
Pages
1634 - 1644
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