ISPE Announces Quality Metrics Pilot Launch

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Renee Smith
Senior Marketing Communications Manager, ISPE
Tel: +1-813-960-2105, ext. 309
Fax: +1 813.264.2816

ISPE Announces Quality Metrics Pilot Launch

—Program to demonstrate the feasibility and value of standard
Quality Metrics is officially underway—

(TAMPA, FLORIDA, USA, 16 June 2014) – At the 3rd annual ISPE-FDA CGMP Conference, ISPE announced the official launch of its Metrics Pilot Program. The launch of the pilot, headed by ISPE’s PQLI® Quality Metrics Team, is a major milestone in the overall project from ISPE. The pilot is now open to any drug manufacturing company that is registered with FDA. The intention is to encourage participation from a broad spectrum of technologies and types of companies within the pharmaceutical industry.

“ISPE is committed is to helping industry identify and define the metrics that are truly indicative of quality,” said Nancy Berg, ISPE’s President and CEO. “Attention to the ‘right’ metrics can help promote positive behaviors and instill in companies a corporate culture of responsibility for quality. ISPE’s Pilot also will explore the opportunities and challenges associated with how metrics are collected and interpreted, as well as consider possible next steps in metrics implementation.”

The ISPE Quality Metrics team was charged with identifying and defining metrics that reflect quality and determining metrics to be applied to sites versus those applied to products. The metrics selected for the pilot were specifically chosen to enable assessment of site, product and quality system performance.

There are multiple benefits that can be achieved from this pilot. Some important primary objectives for the pilot’s initial phase are to:

  • Test harmonization of definitions for industry consensus metrics that represent both leading and lagging indicators
  • Test feasibility of data collection across companies who are at different maturity levels with their own internal metrics programs

Participants also will gain the added benefits of:

  • Blinded comparison among their technology platform peers
  • A head start on establishing internal procedures for metric collection along with a set of metric definitions
  • Insight into implications for metric implementation

The well-attended CGMP Conference also highlighted a broader view of metrics implementation with plenary presentations from US FDA, Pfizer, and Peking University.

McKinsey & Company is partnering with ISPE on the Pilot and will confidentially manage data collection and analysis. Each participant will establish a confidentiality contract with McKinsey.

For additional information about ISPE’s Quality Metrics Pilot and to become a pilot participant, please contact

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Shanghai, China and Frankfurt, Germany. Visit for more information.



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