Quality Metrics Initiative

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ISPE has been leading the charge to bring industry and regulators together to discuss quality metrics ever since it was brought to the forefront of industry thinking in the Food and Drug Administration Safety and Innovation Act (FDASIA).

For the lastest news on ISPE's Quality Metrics Initiative, review the Quality Metrics News page.

What are Quality Metrics?

Following the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the FDA was authorized to collect manufacturing quality data from pharmaceutical companies and obtain certain records from a drug manufacturer in lieu of, or in advance of, an inspection. FDA also was directed to replace the previous two-year drug inspection frequency requirement with a risk-based inspection approach.

The FDA is considering the utilization of quality metrics as an input to its inspection models as well as to predict possible drug shortages, determine inspection schedules for a manufacturer, assess post-market change reporting, and re-structure the format of inspection. To that end, the FDA has invited input from industry on which metrics manufacturers use and find effective to assess processes and their risks.


Routine company metrics include number of lot release tests, out-of-specification results, and lots attempted, rejected, reworked, and reprocessed. However, each company tends to collect data in its own way for its own internal use, using a range of definitions and sampling plans. How firms measure and define “batch,” “lot,” and even “rejection” can differ among companies in different sectors, in the same sector, and even within the same company. Standardization is needed to ensure that the metrics reported to the FDA are defined and measured the same way by all.

What is ISPE Doing?

ISPE has been at the forefront of gathering clear and objective data through its Quality Metrics Pilot Program.

ISPE’s Quality Metrics Team was established in 2013, delivering a first output in December 2013 of the ISPE White Paper on Quality Metrics ( 138 KB).

In 2014 – 2015 the QM team designed and undertook an extensive Pilot Program to test the feasibility of collecting and reporting a standardized set of quality metrics. The primary objectives of the Pilot Wave 1 were to:

  • Test the harmonization of definitions for a set of industry metrics that represent both leading and lagging indicators.
  • Test the feasibility of centralized data collection across companies at different maturity levels within their own internal metrics programs.
  • Explore industry practices in the areas of quality culture and process capability.
  • Inform continued industry input to FDA

Wave 1 of the Pilot met all of its objectives.

  • The learnings of the Pilot Wave 1 were shared with industry and regulators at ISPE conferences in April and June 2015.
  • A full report on Wave 1 is available in the ISPE Bookstore.

Findings from Wave 1 are enabling ISPE and industry to provide data-driven input to the current FDA draft Guidance.

ISPE Quality Metrics Wave 2

The Quality Metrics Wave 2 Report was released at the ISPE/FDA/PQRI Quality Manufacturing Conference held on 6 - 8 June 2016 in Bethesda, MD.  Learn more about the findings included in the report and download it today!

If you have any questions, please contact qualitymetrics@ispe.org.


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