Project to demonstrate the feasibility and value of standard Quality Metrics is officially underway
ISPE, the US International Society for Pharmaceutical Engineering, has officially launched its Quality Metrics pilot programme.
The pilot is now open to any drug manufacturing company that is registered with the US 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 behaviours and instill in companies a corporate culture of responsibility for quality.'
The pilot will also explore the opportunities and challenges associated with how metrics are collected and interpreted, as well as consider possible next steps in metrics implementation.
The metrics selected for the pilot were specifically chosen to enable assessment of site, product and quality system performance.
ISPE says multiple benefits can be achieved from this pilot, including: test harmonisation of definitions for industry consensus metrics that represent both leading and lagging indicators; and test feasibility of data collection across companies at different levels with their own internal metrics programmes.
The organisation says participants will also gain the added benefits of: 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.