Control Strategy is Nexus for QbD Regulatory Paradigm, US and EU Regulators Affirm

CMC review policy makers in the US and Europe are focusing increasing attention on the control strategy as the nexus for the advancing pharmaceutical quality-by-design regulatory paradigm.

Their assessment of the growing body of experience with QbD-oriented applications is revealing the need for sponsors to convey a more in-depth and coherent control strategy to reviewers if the benefits of the new paradigm are to be fully realized.

The pivotal role that the control strategy will play in addressing the remaining regulatory challenges in the QbD implementation process was highlighted by OPS Office of New Drug Quality Assessment (ONDQA) Director Moheb Nasr in a formative presentation at the annual ISPE Washington Conference in June. Nasr has been a steward of the QbD effort both at FDA and internationally through ICH and serves on ICH’s Q8-10 Implementation Working Group (IWG).

Addressing a two-day track at the conference centered around ICH Q8-10 implementation and ISPE’s Pharmaceutical Quality Lifecycle Implementation (PQLI) initiative, he shared his “current and developing thoughts” on why the control strategy is central to the new QbD regulatory paradigm.

The ONDQA director’s remarks encompassed: ● the pharmaceutical quality regulatory challenges prior to QbD ● its introduction and goals ● the progress in QbD implementation ● the regulatory challenges that remain, and ● the role the control strategy will play in solving them (Nasr’s full remarks are provided below).

Nasr’s emphasis on the control strategy was reinforced in other presentations that followed at the PQLI track, including those by ONDQA CMC QbD Lead Sharmista Chatterjee and industry consultant John Berridge.

Chatterjee advised on how to submit the control strategy information within the current common technical document (CTD) framework based on her office’s experience to date with QbD applications (see box below).  Berridge, a key industry player in the ICH quality guideline development process during his career at Pfizer, shared his insights on the overall value of QbD and the importance of the control strategy in realizing it (see IPQ “In the News” July 18 companion story).

European regulators at recent public forums have also been pointing to the control strategy as the capstone of the QbD structure and stressing the importance of conveying enough to reviewers to understand and have confidence in its strength.

The importance of the control strategy to the ICH Q8-10/QbD implementation process has been drawing attention at the ICH level as well.

FDA, EMA and the Japanese Ministry of Health and Welfare (MHO), working together with industry through the ICH Q8-10 IWG, have put together a “points to consider” to help flesh out the control strategy development and submission expectations, which was released on the ICH website in mid-July (see IPQ “In the News” July 18 companion story for a review of the newly posted ICH PTC ).

The issues identified at the 2010 ICH Q8-10 training workshops helped the IWG target the focus of the new PTC (IPQ “In the News” May 1).  Nasr’s presentation at the June ISPE conference, in turn, reflected his participation on the IWG and its work on the PTC.

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