By Dale Curtis Jr., President, Astrix Technology Group
Quality metrics are utilized throughout the pharmaceutical industry to assure product quality and facilitate continued improvement of drug manufacturing processes. The FDA has also shown a significant interest in quality metrics, as data detailing compliance with quality standards in drug manufacturing helps the FDA establish compliance and inspection policies, predict and potentially mitigate future drug shortages, and know how to support and encourage drug manufacturers to implement stat-of-the-art quality management systems.
As evidence of its interest in quality metrics, the FDA published an initial draft guidance in July of 2015 encouraging firms foster a culture of quality and continuous improvement, and signaling its intent to establish a quality metrics reporting program requiring the submission of quality metrics data. A year and a half later (November 2016), responding to comments and some pushback by industry stakeholders, the FDA released a revised draft guidance entitled “Submission of Quality Metrics Data: Guidance for Industry.”