ISPE Product Manufacturing Quality Metrics Initiative

ISPE commenced its Quality Metrics Initiative in June 2013 after the US Food and Drug Administration (FDA) announced its Quality Metrics Program in a February 2013 Federal Register notice.

To assist in the evaluation of product manufacturing quality, FDA is exploring the broader use of manufacturing quality metrics.

Through an extensive series of engagements with industry and other key stakeholders over the past two years, FDA has further indicated that “an objective set of quality metrics” would be reportable to support their risk-based inspection program, as given in sections 704 – 706 of the US FDA Safety and Innovation Act (FDASIA). The FDA Quality Metrics Program is also intended to move both industry and the agency toward the desired state for pharmaceutical manufacturing. The FDA Quality Metrics Program, including the set of metrics selected, is expected to be published for public comment in 2015.

In a white paper delivered to FDA in December 2013, ISPE recommended that a pilot program should be conducted within industry to further understand the implementation opportunities, challenges and benefits available from such a quality metrics program. ISPE, in cooperation with McKinsey and Company, undertook this project. The result was the ISPE Quality Metrics Pilot Project—Wave 1. Designed and developed by the ISPE Quality Metrics Core Team, the project drew on the knowledge and experience of cross-functional industry representatives, ex-regulators and academicians, with further insight gained in detailed discussions with a variety of industry associations at many industry meetings. The ISPE Wave 1 Pilot ran from June through November 2014 and included: