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FDA Lauds St. Gallen's Findings On 10 Metrics For Ensuring Drug Quality

 
• By Joanne S. Eglovitch

US FDA touts new evidence that high performance of pharmaceutical manufacturing sites on 10 quality maturity metrics correlates with robust pharmaceutical quality systems, operational excellence and good business. An FDA-funded study by St. Gallen also finds that low performance, on the other hand, correlates with manufacturing problems.

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An FDA-commissioned report on quality metrics sheds light on how a strong culture improves a pharmaceutical manufacturer’s quality system and ultimately its bottom line. Strong quality maturity or quality culture programs lead to robust pharmaceutical quality systems that can catch major defects early on.

The report also suggests that metrics be incorporated into firms’ operational excellence programs.

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