20/21 December 2022
The FDA has published a supplementing Guide on Quality Metrics. This is a very unusual step as the contents of the guide are planned to be integrated into the Guideline on Quality Metrics which hasn’t been finalised yet.
The so-called FDA Quality Metrics Technical Conformance Guide should supplement the Guidance for Industry: Request for Quality Metrics published on 28 July 2015 which is currently still in the draft version. We have recently published a GMP News about a Quality Metrics Case Study at Aenova regarding a possible implementation. Now, the Technical Guide defines how the industry should submit Quality Metrics to the FDA. Technical standards and fields are defined. Basically, the FDA is oriented towards the data standards which are already established in other areas. FDA‘s so-called Study Data Technical Conformance Guide serves as a basis. Largely widespread in the industry, the XML format is used by the FDA and other authorities for the exchange of data and the submission of data within the marketing authorisation procedure (e.g. for eCTD).
Composed of 10 pages, the Guide primarily provides a definition of the variables necessary for the submission of Quality Metrics. The last page of the Guide refers to "Data Validation Rules". Data Validation is defined as "a process that attempts to ensure that submitted data are both compliant and useful". It should be ensured that the data are submitted in accordance with the required standard. The FDA recognises that the standardisation of data doesn’t ensure the quality of data, but it helps verify certain aspects of data quality thanks to automated checks. When finalising the Guidance for Industry on Quality Metrics, the FDA also wants to set validation requirements on the quality of data in the guideline and thus achieve that companies first perform a validation of their metrics before they submit them.