FDA Issues Draft Guidance on Drug Quality Metrics

The FDA July 27 released a draft guidance for industry on drug quality metrics and also announced that it plans to hold a public meeting in August on its quality metrics reporting program.

Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and “drive continuous improvement efforts in drug manufacturing,” the draft guidance said. “These metrics can also be used by FDA: to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and ...