FDA's Revised Guidance on Submission of Quality Metrics Data
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FDA's Revised Guidance on Submission of Quality Metrics Data
Quality metrics are a key component for the pharmaceutical and biologics industry to monitor the quality control system and process in their manufacturing procedures. These metrics are helpful for FDA to develop inspection policies and practices for drug manufacturers and to inspire the industry to implement up-to-date, advanced quality management systems for pharmaceutical manufacturing.
In line with these goals, FDA issued the first draft quality metrics guidance in July 2015. In response to the comments received from the industry, the Agency released the revised guidance in November, 2016.
Under the revised guidance, the Agency will initiate a voluntary reporting phase of the FDA quality metrics reporting program that will last till 2018. Subsequently, FDA is intended to make the program mandatory.
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What's New in Revised Version?
In the revised guidance, the FDA requires drug manufacturers to provide details for three different metrics instead of four metrics which was initially proposed. These are:
- Lot acceptance rate (LAR) data
- Product quality complaint rate (PQCR)
- Invalidated out-of-specification rate (IOOSR)
Some of the key questions addressed in this guidance are:
- Who reports and who may contribute to a report
- Quality metrics that FDA aims to calculate
- Quality metrics data that can be reported
- How to submit comments within a quality metric data report and in what way to pose questions to FDA
- How to report quality metrics data to FDA
The guidance has addressed these questions and more related to the use of the quality metrics and public reporting to ensure compliance with the FDA regulatory requirements.
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