- 30 сентября 2016
Recently, FDA has published a new technical specifications document entitled Quality Metrics Technical Conformance Guide.
This Guide supplements and serves as the technical reference for implementation of the draft FDA guidance for industry on Request for Quality Metrics and additionally provides recommendations about submission of information that will support the FDA’s calculation of quality metrics.
We have already informed on our website about the draft guidance for industry on Request for Quality Metrics published by FDA last year (in July 2015).
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 are available to patients.
This document describes exchange and file format of electronic submissions as well as general content and format of a submission.
Currently, FDA receives, processes, and archives electronic dataset files in several formats. Extensible Markup Language (XML) shall be the recommended format for Drug Quality Metrics submission.
This new Guide defines also data validation as a process that attempts to ensure that submitted data are both compliant and useful. Compliant means the data conform to the applicable and required data standards. Useful means that the data support the intended use (i.e., regulatory review and analysis). Data validation is one method used to assess submission data quality.
When the FDA guidance for industry on Request for Quality Metrics is published in final, the validation rules will be posted to the external FDA Web page. Establishments should validate their metric data before submission using the posted validation rules and correct any validation errors.