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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...

Key Takeaways

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

  • Better alternatives for predicting quality...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.