Drugs

FDA Quality Management White Paper

FDA has published a white paper, “CDER’s Quality Management Maturity Program: Practice Areas and Prototype Assessment Protocol Development,” which discusses the assessment approach planned to be used at establishments participating in the Quality Management Maturity (QMM) program. The paper says the program’s goals are to:

foster a strong quality culture mindset;
recognize establishments that have advanced quality management practices and acknowledge establishments that strive to continually improve quality management practices;
identify areas where quality management practices can be enhanced and provide suggestions for growth opportunities; and
minimize risks to product availability to assure reliable market supply.

The paper says CDER is developing a prototype assessment protocol covering these five practice areas:

management commitment to quality;
business continuity;
advanced pharmaceutical quality system;
technical excellence; and
employee engagement and empowerment.

The practice areas were identified through a comprehensive review process, the paper says. It also addresses and corrects several possible misconceptions that could arise about the QMM program.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome