Merck Experts Say Burden of QMM Breadth on Individual Companies

The burden is on companies to convince health regulators that an effective quality management maturity (QMM) program is built into its governance structure, according to a pair of Merck executives who spoke Wednesday at the GMP Quality Management vSummit, Oct. 11-12, sponsored by FDAnews, a WCG Company.

Niraj Mehta, executive director of global quality transformation, and Adam Caruso, associate director of global quality strategic programs and regulatory intelligence, explained that drugmakers can achieve higher levels of QMM when they effectively integrate business and manufacturing operations with quality practices and technological achievements to optimize product quality, boost supply chain reliability and drive continual improvement.

And the pair highlighted that the FDA aims to use QMM as an assessment tool to help foster a strong quality culture, recognize establishments that have advanced quality management practices as well as companies that strive to continually improve their practices, identify areas where quality management practices can be enhanced and provide feedback, and minimize risks to product availability to ensure reliable market supply.

To read the whole story, click here to subscribe.

Related Topics