Request for Quality Metrics - FDA Guidance for Industry

The FDA has released a guidance document that includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to collect data and use quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.

Read the guidance:  FDA Request for QualityMetrics - Guidance for Industry (PDF)

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US FDA launches overarching Office of Pharmaceutical Quality - iPT

Updated June 28, 2025

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Read the full article: US FDA launches overarching Office of Pharmaceutical Quality - iPT:

"Within the OPQ, the agency will create an Office of Surveillance, which will be tasked with creating new quality metrics, and will let OPQ inspectors know if they need to inspect manufacturing facilities during an NDA (new drug application) review.

After a new industry range of metrics is published, she added that FDA will take “the first two years to make sure we’re measuring apples and apples” and allow facilities to see where they stack up against competitors.

The agency will undergo the “same type of work but new inspection protocols will be” standardized and help industry understand how pre-approval and surveillance inspections can be done, Woodcock said."

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Guidance Outlining Up to 10 Quality Metrics Expected by Year’s End: FDA Official | 2014-09-26 | FDANews

• FDA GMP Online Training - trusted FDA CGMP online training courses offered by SkillsPlus International Inc.

Guidance Outlining Up to 10 Quality Metrics Expected by Year’s End: FDA Official | 2014-09-26 | FDANews:

"The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year."

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FDA Considers New Quality Metrics

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System | IPQ Newsletter:

"Based on its review of all the responses submitted on the metrics issue, FDA has chosen three that it is considering using and is seeking additional feedback on:

• batch failure rate
• right first time, and
• out-of-specification (OOS)/laboratory failure investigation rates"

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