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FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
FDA released the anticipated draft guidance document for quality metrics on July 28, 2015, detailing the types of data the agency plans to request of drug manufacturers, the uses it plans to make of the data, and the quality metrics it plans to calculate.
The document, Request for Quality Metrics, Guidance for Industry, outlines FDA’s authority to require owners and operators of establishments that manufacture, prepare, propagate, compound, or process human drugs to provide records and information for inspection under section 704 of the Federal Food, Drug, and Cosmetic Act. It also describes the initial set of requests FDA intends to make to certain owners and operators.
As described in the guidance document, FDA intends to apply the quality metrics program for risk-based inspection scheduling, to predict and mitigate drug shortages, improve the inspection process, and improve FDA’s evaluation of drug manufacturing and control operations. Failure to report quality data “may elevate an establishment’s predicted risk in FDA’s prioritization of inspections and many lead to an earlier inspection.” Products associated with an establishment that does not report as required under section 704 (a)(4) (A) may be deemed adulterated and subject to enforcement action.
Planned quality metrics
In the draft guidance document, FDA lists four quality metrics it intends to calculate for each product and establishment, where applicable:
FDA also requested comment on three proposed optional metrics assessing the engagement of senior quality and operations personnel in annual product reviews and product quality reviews; reporting the percentage of corrective actions that involve re-training of personnel; and reporting on the establishment’s process capability or performance index.
Specific data to be reported
The draft guidance document lists the following data types to be reported.
FDA intends to request that establishments submit quality metrics data reports for a one-year period that begins after the agency issues its requests, as specified in the request. Reports would be due within 60 days of the end of the reporting period. The data would be segregated in in the report on a quarterly basis. Submission would be through the FDA Electronic Submissions Gateway.
The draft guidance document is available for review on FDA’s website. Comments and suggestions can be submitted for 60 days on regulations.gov.
View the Request for Quality Metrics draft guidance document