At the 3rd annual ISPE-FDA CGMP Conference, ISPE (International Society for Pharmaceutical Engineering) 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.