FDA’s Office of Generic Drugs (OGD) is making significant strides forward in its efforts to implement quality by design (QbD), refine its review processes and implement a quality management system, in anticipation of the resource underpinning that user fees will provide.
On the QbD front, OGD has developed two case studies providing insight into what the office is looking for regarding oral solid immediate release (IR) and modified release (MR) dosage forms, respectively.
The office held workshops in conjunction with the Generic Pharmaceutical Association (GPhA) focused on the examples and their refinement in May 2010 (IR) and May 2011 (MR). The release of refined drafts of the two examples for comment and further discussion with industry is expected shortly.
Reviewer training on QbD is ongoing and another round of workshops with industry is planned for later this year. QbD training was held this past fall for the office’s CMC leadership, which reviewed the potential revisions to its question-based review (QbR) system. Further training for CMC reviewers is anticipated during this spring.
Catalyzing a multifaceted effort to improve generics office review processes was a four month study by the consulting firm McKinsey completed in the spring of 2011. The OGD study followed in the wake of a McKinsey report prepared for FDA in 2009 on QbD uptake, challenges, and its potential impact on industry and regulatory processes (link provided below).
In response to the study, OGD has developed a four-pronged effort to refine and streamline its processes. The initiatives are addressing:
● tightening the filing criteria to delimit the extra workload and time involved in remedying problems in the applications later when they are under review
● implementing cross-discipline review and project management teams to better coordinate the flow of applications through the approval pipeline and facilitate a tracking dashboard
● separating out the active pharmaceutical ingredient (API) drug master file (DMF) review from the drug product review to allow more specialization and better accommodate the tight generic drug user fee act (GDUFA) API/DMF goals, and
● the increased use of complete response (CR) letters and other communication tools to assure the clarity and transparency of application status and deficiencies as called for under GDUFA.
The quality management system that OGD is developing calls for improving the documentation and clarification of procedures and their consistent application across the different office divisions toward achieving the efficiencies that GDUFA is mandating.
[The in-depth story continues here and includes the insights and analysis of the OGD workload, initiatives, goals and user fee implications provided by acting director Keith Webber at the GPhA 2011 Fall Technical Conference. Non-subscribers can purchase the complete story for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here.]
See related IPQ stories:
Generic Drug Manufacturing Issues Draw FDA Warning Letters at Sandoz and Mylan
