FDA Issues Quality Metrics Technical Conformance Guide


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-28-2016 14:42

  

The US Food and Drug Administration (FDA) has issued the Quality Metrics Technical Conformance Guide, a technical specification document, to serve as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality Metrics. 

The draft guidance, Request for Quality Metrics and this technical reference document continue the FDA’s policy efforts to ensure successful implementation of the Center for Drug Evaluation and Research's objective regarding good manufacturing practices for the 21st century. The FDA expects that quality metrics calculated from data that it collects will provide objective measures that, when used with additional internal data, will provide the agency with indicators of the effectiveness of pharmaceutical manufacturing quality systems.

The goal of these measures is to assure quality drug products. The objectives of CDER’s quality metrics program can best be achieved through collaboration and a shared understanding of standards for metric indicators and data exchange/reporting. The guide supplements the draft FDA guidance for industry on Request for Quality Metrics and provides recommendations about submission of information that will support the FDA’s calculation of quality metrics.

FDA's Quality Metrics Initiative arose followin the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, under which the FDA was authorized to collect manufacturing quality data from pharmaceutical companies and obtain certain records from a drug manufacturer in lieu of, or in advance of, an inspection. FDA also was directed to replace the previous two-year drug inspection frequency requirement with a risk-based inspection approach. As part of the agency's initiative, the FDA is considering the utilization of quality metrics as an input to its inspection models as well as to predict possible drug shortages, determine inspection schedules for a manufacturer, assess post-market change reporting, and re-structure the format of inspection. To that end, the FDA has invited input from industry on which metrics manufacturers use and find effective to assess processes and their risks.

Source: FDA

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