The FDA Group's Nick Capman discusses the recent news that the FDA is once again returning to its quality metrics program for pharma manufacturers.

The agency’s focus on quality metrics began in 2015 and continued with a heavily revised draft guidance on submitting metrics data, including quality-related complaints. The guidance led to two FDA pilot projects in 2018.

In a new update, FDA stressed that additional quality data can help both the FDA and the supply chain, which needs to have a better understanding of which manufacturers are going above and beyond the status quo.

Current GMP compliance “does not necessarily indicate” whether a manufacturer is investing in improvements and striving for consistent control over its manufacturing performance and quality, FDA said.

“To provide flexibility to manufacturers, FDA would focus less on standardization of quality metrics and definitions,” the agency said Tuesday. “Instead, FDA would identify practice areas that are critical to ensure sustainable product quality and availability and would permit manufacturers to select a metric(s) from each practice area that are meaningful and enable establishments to identify continual improvement opportunities.”

Rather than set metric definitions on how establishments calculate particular metrics, the FDA said it will allow reporting establishments (i.e. API and finished dose manufacturers, among others) to select the most appropriate metric(s) from each practice area and inform FDA how the metrics were calculated.

Based on feedback from the pilot participants, the agency said it identified four general areas as appropriate for its metrics program:

Manufacturing process performance
Pharmaceutical quality system effectiveness
Laboratory performance
Supply chain robustness

Examples of quality metrics associated with each of these areas include (for area number 1) a metric on the proportion of lots manufactured without the occurrence of a non-conformance, (for area number 2) a measure of the proportion of recurring deviation measures, (for area number 3) a measure that indicates a lab’s ability to accurately perform tests, and (for area number 4) a measure of the extent to which shipments are delivered to their destination containing the correct quantity and according to the order’s schedule.

As far as questions for industry, the FDA wants to know if stakeholders agree that reporting should be aggregated at an establishment level, and whether reporting at an establishment level would help facilitate the submission of quality metrics data by contract manufacturers.

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FDA Revives Its Proposed Quality Metrics Program for Pharma

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