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McKinsey Survey Highlights Progress, Challenges in Adoption of QbD

This article was originally published in The Gold Sheet

Executive Summary

Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.

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FDA Warns Generics Firms About January QbD Deadline for ANDAs

Come January, if there is no quality target product profile (QTPP) in an abbreviated new drug application (ANDA), FDA might not file it, agency officials told a Generic Pharmaceutical Association workshop. Even though quality by design (QbD) remains optional for brand drugs, it will be expected for generics, said Office of Generic Drugs representatives who went on to outline pending question-based-review (QbR) revisions designed to elicit QbD information.

Regulators Discuss QbD Challenges While Industry Attests That Business Benefits of QbD Still Unknown

Regulators in the European Union and U.S. say that the concepts of design space, control strategy, and critical quality attributes are confusing to pharmaceutical manufacturers and are working to address this to ease quality by design implementation. In the meantime industry representatives say that it is still too early to make a definitive business case for QbD but that early signs are promising.

Regulators Discuss QbD Challenges While Industry Attests That Business Benefits of QbD Still Unknown

Regulators in the European Union and U.S. say that the concepts of design space, control strategy, and critical quality attributes are confusing to pharmaceutical manufacturers and are working to address this to ease quality by design implementation. In the meantime industry representatives say that it is still too early to make a definitive business case for QbD but that early signs are promising.

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