> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CDER To Issue Revised Draft Guidance on Quality Metrics
- URL: https://www.fdaweb.com/cder-to-issue-revised-draft-guidance-on-quality-metrics/
- Published: 2016-08-10T12:00:00.000Z
- Updated: 2026-09-14T21:23:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136473

CDER has decided to scrap its 2015 new [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455957.pdf?ref=fdaweb.com) on *Request for Quality Metrics*, and it plans to replace it with a revised draft document later this year on *Submission of Quality Metrics Data*. “After carefully considering the numerous technical and regulatory comments received to the docket for the initial draft guidance,” an FDA spokesperson told ***FDA Webview*** 8/10, “FDA intends to issue a revised draft guidance to outline a revised program that incorporates many of the substantive stakeholder comments. The revised draft guidance, when issued, will be accompanied by another open comment period to gain further stakeholder input in the revised program.”

The 2015 draft outlined the data FDA planned to request from pharmaceutical and biologic manufacturers as part of its risk-based inspection program. For example, it said the metrics would help the agency calculate the following:

- Lot Acceptance Rate = 1 –x (x = the number of specification-related rejected lots in a timeframe divided by the number of lots attempted by the same establishment in the same timeframe).
- Product Quality Complaint Rate = the number of product quality complaints received for the product divided by the total number of lots of the product released in the same timeframe.
- Invalidated Out-of-Specification (OOS) Rate = the number of OOS test results for the finished product invalidated by the establishment divided by the total number of OOS test results divided by the total number of tests performed by the establishment in the same timeframe.
- Annual Product Review (APR) or Product Quality Review (PQR) on Time Rate = the number of APRs or PQRs completed within 30 days of annual due date at the establishment divided by the number of products produced at the establishment.

“While FDA recognizes the value of quality metrics, we also recognize that individual data points and metrics are not solely indicative of the state of quality of the establishment or products,” the guidance said. “Rather, FDA intends to use quality metrics data in context with other sources of quality data... FDA intends to use quality metrics data to further develop FDA’s risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA’s evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for post-approval manufacturing changes.”

Pharmaceutical Research and Manufacturers of America was critical of CDER’s quality metrics plan ([see story](http://fdaweb.com/login.php?sa=v&aid=D5135098&searchWords=quality%20metrics&cate=S&stid=%241%24%2F03.aI2.%24pPm51WA1grbRFMG0zpHAJ0&ref=fdaweb.com)). The group said the agency should provide more transparency on how it plans to process, interpret, and use the data. It also urged FDA to clarify that it will continue to protect manufacturers’ confidential commercial information when it collects quality metrics data. “Such information must continue to be protected in order to avoid unintended consequences if the data were taken out of context, misinterpreted or misused,” it said. “PhRMA has requested that FDA explicitly state it will protect biopharmaceutical companies’ confidential commercial information when used as part of the quality metrics program.”

Additionally, PhRMA called on FDA to phase-in the program to make it possible to incorporate lessons learned by stakeholders over time. “A phased-in approach … would help to balance the potential benefits with any unnecessary burden for both the agency and industry so that we can both continue to meet our shared goal of protecting and promoting patient health,” the group said.