ISPE Launches Quality Metrics Pilot Program


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-18-2014 16:00

  
The International Society for Pharmaceutical Engineering (ISPE) announced the official launch of its Metrics Pilot Program. The pilot is headed by ISPE’s PQLI Quality Metrics Team, which is 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

The pilot is open to any drug manufacturing company that is registered with the US Food and Drug Administration. The intention is to encourage participation from a broad spectrum of technologies and types of companies within the pharmaceutical industry. 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 and to test feasibility of data collection across companies who are at different maturity levels with their own internal metrics programs. The pilot will also offer participants a blinded comparison among their technology platform peers; a head start on establishing internal procedures for metric collection along with a set of metric definitions; and insight into implications for metric implementation.

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.

Source: ISPE

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