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Quality issues are still the number one reason for drug shortages, and in an effort to address this, the U.S. Food and Drug Administration is debuting a quality management maturity (QMM) program intended to incentivize drugmakers to invest in quality measures.
The program will be run by the FDA’s Center for Drug Evaluation and Research (CDER), which is developing its QMM Assessment Tool to evaluate how effectively establishments monitor and manage quality and quality systems. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.
In a white paper, the FDA cited four main goals: foster a strong quality culture mindset; recognize establishments that have advanced quality management practices and acknowledge establishments that strive to continually improve them; 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.