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.

Citing a McKinsey article on why management should embrace QbD, Yatindra Joshi, VP of generics R&D at Teva Pharmaceuticals, asked attendees at FDA’s July 27 Advisory Board meeting on QbD, “Can we do without QbD in generics?” Mr. Joshi presented on behalf of the Generic Pharmaceutical Manufacturers Association.

Not using QbD, at this point, is not an option, given mandates for low cost and uninterrupted supply, he said.

Joshi suggested that the Design Space and PAT should not be required for generics manufacturers, but used on a case by case basis. However, he noted the pressure to be first to file, and concerns about the cost of investing in QbD.

FDA’s Office of Generics is already using more elements of QbD in its question-based review process. At a QbD conference in June, sponsored by NIPTE, Lane Christensen from FDA’s Office of Generics discussed the question-based review (QBR) process, initiated nine years ago.  Click here to access his presentation. Within the program’s first year, he said, nearly 100% of ANDAs were submitted in QBR format.  More elements of QbD are being incorporated into QbR, he said.

He offered some sample questions:

• Do differences between the formulation and the RLD present potential concerns with respect to therapeutic equivalence?
• Which properties or physical chemical characteristics of the drug substance affect drug product development, manufacture or performance?
• What evidence supports compatibility between excipients and drug substance?
• What is the scaleup experience with unit operations in the process?
• How were critical variables controlled?
• What was scaleup experience with unit ops?
• How were CPPs identified monitored or controlled?
• Were alternative formulations or mechanisms investigated?

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