Pharma Manufacturing Quality: Optimizing Processes for FDA Compliance

Saturday, April 19, 2008 General News J E 4
CHAPEL HILL, N.C., April 18 With safety issues makingheadlines, pharmaceutical and medical device manufacturers face a ruggedregulatory landscape. Organizations are relying on their quality function tonavigate regulatory difficulties that could affect production. Proper staffingof quality roles is just one way organizations optimize their quality functionand a study by pharmaceutical benchmarking leader Best Practices, LLC foundbest-in-class companies have a ratio of quality personnel to totalmanufacturing 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 practicesin quality harnessed from survey responses and in-depth interviews with seventop pharmaceutical and medical device company leaders. A complementaryexcerpt is available at .

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

To find out more about Best Practices Research and Consulting, pleasevisit our website at or contact Grant Houston at919-767-9182 or


Best Practices, LLC is a research and consulting firm that conducts workbased on the principle that organizations can chart a course to superioreconomic performance by studying the best business practices, operatingtactics and winning strategies of world-class companies. For more information,call (919) 403-0251 or visit* 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

SOURCE Best Practices, LLC


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