FDA News

Pharma Manufacturing Quality: Optimizing Processes for FDA Compliance

(Aprl 21, 2008)--  A complementary excerpt is available at http://www3.best-in-class.com/rr930.htm .With safety issues making headlines, pharmaceutical and medical device manufacturers face a rugged regulatory landscape. Organizations are relying on their quality function to navigate regulatory difficulties that could affect production. Proper staffing of quality roles is just one way organizations optimize their quality function and a study by pharmaceutical benchmarking leader Best Practices, LLC found best-in-class companies have a ratio of quality personnel to total manufacturing employees between 1:4 and 1:7.

As captured in the benchmarking report, The Quality Function: Structure, Staffing and Execution, Best Practices, LLC, reveals strategic best practices in quality harnessed from survey responses and in-depth interviews with seven top pharmaceutical and medical device company leaders.

Executives from Abbott, Lilly, J&J, GlaxoSmithKline, Wyeth and others shared wisdom and key insights for honing elite quality functions within their organizations. A sampling of their tactics and best practices includes:

* Heighten intra- and inter-company transparency: Disseminate information about weak areas within the company and competitor companies among quality staff, as reflected in regulatory consent decrees and warning letters obtained from FDC publications and Gold/Green/Pink Sheets.
* Establish action-triggering metrics: Develop reporting mechanisms that bring performance measurements and deviation reports before the eyes of senior management.
* Focus quality personnel on activities/results not measures: Employ integrated improvement charts to effectively communicate important measures to focus actions by responsible parties. E.g., 3-in-1 charts

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