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Quality-by-design was first described by Joseph M. Juran, is a systematic approach to drug development, which begins with
pre-defined objectives, and uses science and risk management approaches to gain product and process understanding
and ultimately process control. The FDA has recently begun to advocate the QbD methodology for the pharmaceutical sector.
More companies in the pharmaceutical industry today are in the need of adopting the principles of Quality-by-design (QbD)
to the development of analytical methods in addition to the development of manufacturing processes. As such, both industry
and regulators recognize the benefits of adopting a QbD approach to drug-product development and manufacture, with key
concepts described in the International Conference on Harmonization (ICH) guidelines, Q8 (R1) Pharmaceutical Development,
Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. Drug development using the principles of QbD can be
introduced as two key concepts that further aid in implementation. The first concept is the ?design space? that generally involves
the identification of the critical attributes for the input materials, the process, and the final product. Another important concept
is that of the ?control strategy? which is to ensure the final quality of the product. Some of the concepts are more applicable
than others, and some have been advocated by many method development experts for some time, but modern technology has
created an opportunity to revisit strategies for creation of chromatographic methods in particular, and it is certainly interesting
to investigate the new opportunities in the context of Quality by Design. The ultimate goal is to highlight the QbD concepts and
terminology can be applied to analytical methods and to suggest how adoption of a QbD approach might be used to develop more
robust analytical methods and effective control systems.
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