Categorized | Expert Insights, QbD News

A Renewed Call for FDA to Provide a Clearer Path

    A Renewed Call for FDA to Provide a Clearer Path

    Yesterday, consultants Howard Levine, Susan Jones, and Alex Kanarek of BioProcess Technology Consultants posted an item on their BioProcess Blog–titled “The Ongoing Challenges of Applying QbD to Biopharmaceutical Products“–reflecting upon events at the recent BioProcess International confererence in Providence. In particular, the trio discuss OPS Director Helen Winkle’s keynote talk on “regulatory modernization,” and Winkle’s summary of a recent proprietary report conducted by McKinsey & Co. that suggested that FDA needs to get its QbD house in order. Write Levine, Jones, and Kanarek:

    The McKinsey study found the biotech industry “stepping up to the plate” in adopting QbD and that QbD is “evolving, gaining momentum, and passion throughout the industry.” Meanwhile, FDA wrestles with its internal contradictory views, leaving companies with little or no guidance on the development of QbD programs and the definition of specific process design spaces beyond what is coming from the analysis of submissions in the QbD Pilot Programs.

    In his column in the October issue of Pharmaceutical Manufacturing (which we’ll post here on soon), Step Change Pharma consultant Ali Afnan also references the McKinsey report, and a talk earlier this year by McKinsey’s Ted Fuhr. Afnan writes: “On the subject of QbD’s adoption by pharmaceutical companies, [Fuhr] concluded, ‘Many believe that the business case for QbD is strong, but a large percentage are still skeptical.’ He also reported that only 22% of research-based firms . . . have fully implemented QbD, while generics and biologics firms have yet to adopt the concept.”

    While many in biopharma and elsewhere may see the logic and even the ROI of QbD, they still view implementation as somewhat of a regulatory risk. And many in the industry would of course like to see the McKinsey report. During the Q&A that followed Winkle’s talk, Levine asked if the report might be made public. Winkle responded that she hoped it would be possible, but that the Agency still needed “to work out the details.”

    Levine et al. conclude their post by expressing the frustration that many in the industry no doubt feel: “We only hope the agency gets its house in order soon and provides industry with a unified clear path forward,” they say.

    –Paul Thomas

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    One Response to “A Renewed Call for FDA to Provide a Clearer Path”

    1. epcotint says:

      I am sorry to say that FDA does not have to provide a path of how to improve processes. We the developers have to demonstrate how we can create a robust and sturdy process that will deliver quality all the time.

      FDA established the rules and regulations because our processes did not deliver what they were meant to do.

      The ball is in our court. Let us see how we play.


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