ISPE Pilot Program Promotes Pharma Manufacturing Quality

At its 3rd annual ISPE-FDA CGMP Conference, ISPE announced Monday it has officially launched its Metrics Pilot Program, geared to help identify and define metrics that indicate quality in the pharmaceutical manufacturing industry. The pilot program is spearheaded by ISPE’s PQLI® Quality Metrics Team, and is now open to any drug manufacturing company that is registered with the FDA.

The goal for the ISPE Quality Metrics team is to identify and define "metrics that reflect quality and determine metrics to be applied to sites versus those applied to products," according to the organization. The metrics selected for the pilot were specifically chosen to enable assessment of site, product and quality system performance.

“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.”

Although the program hopes to achieve a number of goals in its initial phase, ISPE's primary objectives include testing harmonization definitions within the pharma manufacturing industry for both leading and lagging indicators, as well as feasibility data collection across companies.

Participants in the program will gain valuable knowledge, stemming from blind comparison among technology platform peers, a head start to establish internal metrics procedures, and insights into implications for metric implementation.

Data collection and analysis will be strictly confidential.  In fact, each pilot participant will sign a confidentiality contract with ISPE's partner McKinsey & Company.