FDA’s Generics Office is Revising its QbR Questions to Sharpen Focus on QbD and Control Strategy

FDA’s Office of Generic Drugs (OGD) is revising the questions underpinning its Question-based Review (QbR) approach to sharpen their focus on the quality-by-design (QbD) and control strategy information the office wants industry to provide in Abbreviated New Drug Applications (ANDAs).

OGD will be issuing the revised questions in draft form for comment this fall, in line with its goal of making QbD a prerequisite for ANDA approval in 2013.

OGD management stresses that the QbR revision will focus more attention on: ● the quality target product profiles (QTTP) – the elements that the generic product needs to have in order to conform to the reference listed drug (RLD) ● product/process design understanding, and ● the control strategy for assuring the quality of the products that are leaving the plant.

At a CMC workshop co-sponsored by the Generic Pharmaceutical Association (GPhA) and FDA in late May, OGD CMC Reviewer Jennifer Maguire walked the industry attendees through the changes to the questions, explaining the motivation for the rewording and what specifically the office would be looking for in the company responses to them.

Maguire noted that the revision was intended to “fully incorporate QbD elements and to be consistent with ICH Q8” as well as to elicit more meaningful responses “based on the lessons learned over the past five years.”

On the latter motivation, she commented that “some of the wording has been improved to encourage applicants to respond with adequate information. Hopefully we will eliminate the need for some of the more common deficiencies” that OGD reviewers have seen since QbR was implemented in 2007.

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See related stories:

The Role of QbD in ANDA Review Draws Comment from Generics Office Management

FDA Generic Drugs Office Advances QbD, Review Processes and Quality Management System in Anticipation of User Fees

IPQ Special Report May 2010, pp. 17-19