News about GMP/cGMP

04.07.2016

FDA Issues Technical Conformance Guide for Quality Metrics

The FDA has issued a 10-page technical specifications document providing recommendations on the submission of data to support quality metrics as part of the process validation lifecycle and pharmaceutical quality system assessment. The guide serves as the technical reference for implementation of the draft FDA guidance “Request for Quality Metrics” that was published in July 2015 and can be seen as a supplement.

 

The guide addresses:

  • Electronic submission – exchange format, file format
  • Data element specifications
  • Mandatory data elements and
  • Optional data elements
  • Data validation rules.

Data validation, regarding quality metrics, is defined as “a process that attempts to ensure that submitted data are both compliant and useful.” Furthermore, FDA says that “Data validation is one method used to assess submission data quality” and that “The data validation process can identify data issues early in the review that may adversely affect the use of the data.”

When the FDA guidance for industry on "Request for Quality Metrics" is published in final, the validation rules will be posted on the external FDA Web page. The FDA points out that establishments should validate their metric data before submission using the posted validation rules and correct any validation errors.


Source:

FDA: Technical Conformance Guide for Quality Metrics

 



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