ISPE Hits Recruitment Milestone for Quality Metrics Pilot Program - - BioPharm International


ISPE Hits Recruitment Milestone for Quality Metrics Pilot Program

ISPE announced on Aug. 8 that its Quality Metrics Pilot Program has achieved a milestone with confirmation of 12 companies and 32 sites participating, even as recruitment continues. The participating companies represent generic, innovator, over-the-counter, contract manufacturing, and analytical businesses with solid dosage, sterile, drug substance, small and large molecule technologies.

At a meeting of the Quality Metrics team during the week of July 14, arrangements were made to establish multiple forums that will enable participating companies to influence the outcome of the Pilot Program. There are also opportunities for participants to develop insights into the quality performance of their sites, ISPE reports. Participating companies will provide up to 12 months of historic and a limited amount (3 months) of current data as Wave 1 of the Program.

A planned Wave 2 will expand the number of participants; assess a potentially adjusted metric set based on learning from Wave 1 and status of any regulatory announcements; include input from sub teams working on Leading Quality Indicators/Quality Culture and Process Capability; be based more on current data collection and analysis; and consider cooperating with other groups and associations.

The objective of the Pilot Program is to provide experiential input on the development and use of quality metrics for the benefit of both industry and regulators.

Source: ISPE

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