Tag Archive | "generic drugs"

Is QbD a Mandate for Generics? FDA Responds to Confusion

By Paul Thomas, Senior Editor

Last fall, FDA’s Lawrence Yu, deputy director for science and chemistry in the Office of Generic Drugs, said the following:

“As we’ve said many, many times, FDA Office of Generic Drugs expects QbD applications starting January 2013. You heard right, full implementation of QbD in January 2013.”

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QbD for Generics: An Update

FDA’s Office of Generic Drugs and the Generic Pharmaceutical Association (GPhA) have been working together to develop more specifics on how QbD can be applied to generic products. Now posted on the Agency’s website are a collection of presentations from last fall’s OGD/GPhA technical conference.

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Making Cents: QbD Must Shift Its Focus

By Bikash Chatterjee, President and CTO, Pharmatech Associates

It has been nearly eight years since ICH first rolled out its concept paper on Pharmaceutical Development defining the framework for Quality by Design (QbD) and nearly seven since the FDA first embraced the concept in its 2004 guidance on Risk based cGMPs. During that time the industry has been warming up to the benefits of QbD. While adoption has been slow, it is gaining momentum.

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Teva’s Joshi: Not Using QbD for Generics is “Not an Option”

by Agnes Shanley

McKinsey’s state of the industry report on QbD alluded to the fact that requiring some aspects of a QbD approach to generic pharmaceuticals would improve quality, a critical consideration since generic drugs now account for 72% of all prescriptions filled in the U.S.

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Case Studies: QbD for ANDAs

This week in Bethesda, the Generic Pharmaceutical Association (GPhA) and FDA are hosting a workshop on the application of Quality by Design to ANDAs, the purpose being to provide more insight as to how QbD can be leveraged within the generics sector. (The event is sold out, which is a good sign.) In conjunction with the meeting, GPhA has posted two comprehensive draft case studies:

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A QbD Implementation Roadmap for the Generics Industry

By Bikash Chatterjee, President and CTO, Pharmatech Associates

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