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Pharmaceutical Industry Adopting QbD for Analytical Testing

 
• By Joanne S. Eglovitch

Both the pharmaceutical industry and regulators are exploring new QbD approaches for analytical method development. FDA regulators have approved analytical QbD submissions and say that regulatory relief will be granted to those firms that use this approach, while the EU has been less accepting.

Pharmaceutical manufacturers are developing quality-by-design approaches for their analytical testing programs as a way to improve process robustness, while FDA regulators are encouraging these approaches.

FDA officials say that regulatory relief will be granted to firms that implement QbD in their analytical testing programs.

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