Revised Draft Guidance for Industry: Submission of Quality Metrics Data

Revised Draft Guidance for Industry: Submission of Quality Metrics Data

FDA is issuing a revised draft guidance on Quality Metrics that includes an explanation of how CDER and CBER intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry. 

As described in this guidance, FDA is initiating a voluntary reporting phase of the FDA quality metrics reporting program, through which we expect to learn more about a limited set of quality metrics, associated analytics, and improve the FDA quality metrics reporting program. FDA will accept voluntarily submissions of data from owners and operators of human drug establishments. 

Additional information is located at:

• FDA’s  Quality Metrics Webpage
• Webinar on "Revised Draft Guidance for Industry: Submission of Quality Metrics Data"
• Federal Register Notice
• Revised Draft Guidance: Submission of Quality Metrics Data