Key pillars for global pharmaceutical companies in building effective quality cultures within their organizations and extending them to their contract partners are commitment and communication by senior management, openly sharing inspection information across sites, and a quality-by-design (QbD) approach beginning in early development, industry executives maintain.
Implementing a quality mindset can be especially daunting for generics firms, where the tension between establishing robust quality processes and first to file status together with thinner budgets create unique challenges and trade-offs.
At a quality systems/ICH Q10 conference cosponsored by the associations PDA and ISPE in conjunction with FDA and EMA in Arlington, Virginia in October, a panel comprised of quality and manufacturing senior executives from several large pharma companies assessed the anatomy of a quality culture.
Topics discussed by the execs included the importance of: ● sharing inspection information ● robust processes vs. first to file ● instituting a quality culture throughout a global company and its vendors ● senior leaders understanding and talking about quality, and ● creating and implementing quality plans.
The panel Q&A session followed a thought-provoking talk by Sandoz CEO Jeffrey George on the importance of management support for continual improvement in the generics context. George’s comments reflected his experience as the new CEO at Sandoz in addressing the compliance issues that FDA has raised at some of Sandoz’ facilities over the last few years (IPQ “In the News” January 3, 2012).
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