Authors: Ron S Kenett Dan A Kenett
Publish Date: 2008/09/30
Volume: 13, Issue: 12, Pages: 681-690
Abstract
A process is well understood when all critical sources of variability are identified and explained variability is managed by the process design and monitoring and product quality attributes are accurately and reliably predicted over the design space Quality by Design QbD is a systematic approach to product development and process control that begins with predefined objectives emphasizes product and process understanding and sets up process control based on sound science and quality risk management The Food and Drug Administration FDA and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH have recently started promoting QbD in an attempt to curb rising development costs and regulatory barriers to innovation and creativity QbD is partially based on the application of multivariate statistical methods and a statistical Design of Experiments strategy to the development of both analytical methods and pharmaceutical formulations In this paper we review the basics of QbD and their impact on the innovative generic and biosimilar pharmaceutical industry In particular we consider the challenge of mapping the control space in biotechnological processes and how advances in statistical methods can contribute to QbD
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