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Quality Management Maturity Scheme Questioned As US FDA Seeks Testers For Next Phase

 
• By Bowman Cox

Agency asks manufacturing facilities to volunteer for prototype quality management maturity assessment protocol, while industry questions overall direction of QMM program and points to emergence of better ways to predict quality and reliability.

Data analytics
quality data analytics are expected • Source: Shutterstock

A month after receiving mixed input from pharmaceutical industry groups on its quality management maturity initiative, the US Food and Drug Administration has asked the industry to take another step forward with the deliberately paced effort, even as powerful new predictive capabilities are overtaking it.

The FDA’s Center for Drug Evaluation and Research on 25 January asked drug manufacturing establishments for volunteers to evaluate a protype of its protocol for periodically assessing their quality management maturity

Key Takeaways

  • QMM is FDA’s way to highlight quality and reliability of pharmaceutical supplies.

  • Better alternatives for predicting quality are emerging as QMM advances slowly amid industry resistance

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