Raising the Bar on Biopharma Manufacturing Quality

Raising the Bar on Biopharma Manufacturing Quality

          
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Raising the Bar on Biopharma Manufacturing Quality

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  • It’s proving very hard to move the needle. Over the last several years, the biopharmaceutical industry worldwide has intensified its focus on quality in manufacturing—but with little to show for it. Manufacturing quality levels remain well below those in other industries, such as semiconductor manufacturing and aerospace. And major recalls are still all too common. From 2010 through 2014, 11 of the top 15 biopharmaceutical companies (by revenue) received warning letters from the US Food and Drug Administration. Such problems can come at a steep price—in some cases, hundreds of millions of dollars in lost revenue, remediation costs that run in the tens of millions of dollars, and a big hit to the company’s reputation.

    There are a number of reasons for the persistent quality challenges. First, the focus on quality has itself too often meant racing to put out fires when compliance issues surface, instead of addressing the root causes of quality problems. Increased investment in areas such as quality personnel or software can help in the short term, but the resulting improvements are rarely sustained and are not always commensurate with the investment. Second, when a company does implement a program aimed at delivering long-term results, it is often rolled out in a rigid, one-size-fits-all manner that ignores differences among manufacturing plants and their progress in improving quality. The result can be programs that are poorly matched to individual facilities and that miss the root causes of their quality problems. Further, such programs typically reside exclusively within the quality function and fail to address organization-wide processes that can have a major impact on quality.

    It doesn’t have to be this way. Companies can improve the effectiveness and efficiency of their quality efforts by crafting and implementing a comprehensive program that takes the entire supply chain into account, from the materials provided by key vendors to production, packaging, disposition, and distribution. To do so, they need to squarely address the factors that drive success in the three phases of
    a quality improvement program:

    • Designing the program to meet clearly defined business objectives, such as accelerating new-product launches, and to allow flexibility in how quality tools are deployed at the plant level.
    • Implementing the program so that it engages all functions in the biopharma supply chain and is oriented around outcomes. Central to this is the tracking of actionable data so that steps can be taken to resolve problems such as high deviation rates.
    • Embedding the right focus and culture so that the program can be sustained and improved. A quality-centric culture gives employees a clear understanding of how their actions affect quality and business results.

    In embracing this approach, biopharmaceutical companies will be following the example of other industries in which such strategies have had powerful results.

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