Pharmaceutical Industry Adopting QbD for Analytical Testing

By Joanne S. Eglovitch / Email the Author / “The Gold Sheet” January 2012, Vol. 46, No. 1
Word Count: 2488 / Article # 08120126001

Executive Summary

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.

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Subjects
Regulatory
Industries
Biopharmaceuticals
Companies
GlaxoSmithKline PLC
GlaxoSmithKline Inc.

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