Quality metrics are used throughout the drugs and biologics industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be useful to 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 to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing. This revised draft guidance includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize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.

In order to achieve these goals, FDA is initiating a quality metrics reporting program. As described in this guidance, FDA is initiating a voluntary reporting phase of the FDA quality metrics reporting program. In the voluntary reporting phase of the program, FDA expects to learn more about a limited set of quality metrics, associated analytics, and improve the FDA quality metrics reporting program.

During the voluntary phase of the reporting program, FDA will accept voluntarily submissions of data from owners and operators of human drug establishments. FDA expects that the large majority of voluntary reports will be submitted by establishments engaged in the manufacture, preparation, propagation, compounding, or processing of finished dosage forms (FDF) of “covered drug products” or active pharmaceutical ingredients (API) used in the manufacture of “covered drug products.”

The voluntary reporting phase of the program described in this guidance is not focused on reporting from certain CDER regulated manufacturers (i.e., compounders operating under section 503A or registered as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or CBER regulated manufacturers of blood and blood components for transfusion, vaccines, in vitro diagnostics, cell therapy products, gene therapy products, allergenic extracts, human cells, tissues, and cellular and tissue based products).

Posted on the FDA website on 23 November 2016