ISPE Quality Metrics Pilot Program Plans Proceeding

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16 April 2014

ISPE announced last month that it will conduct the industry’s first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the U.S. Food and Drug Administration (FDA). The year-long program will test a series of leading and lagging indicators that could support an FDA risk-based inspection program in lieu of biennial inspections, as directed by the Food and Drug Administration Safety and Innovation Act (FDASIA).

ISPE will work with McKinsey & Company in order to conduct confidential plant-level data gathering and analysis. McKinsey will establish a confidential database to be used only for this pilot. McKinsey’s role will be to serve as an independent third party to collect and validate reported data to ensure that confidentiality around company-specific data is preserved, as well as to ensure consistency in interpretation and reporting by individual companies.

In this project, McKinsey will establish a confidentiality agreement with each participating company, and will charge a fee to participating companies in order to cover the cost of data collection and analysis. McKinsey will report individual company results back to respective companies, along with comparisons to the full industry-wide pilot sample. McKinsey will contribute blinded industry-level analyses to the ISPE PQLI® Team and to participating companies in order to inform pilot analyses and recommendations.

The ISPE Product Quality Lifecycle Initiative (PQLI®) Metrics Team will provide overall project oversight supported by the ISPE Board of Directors and the PQLI Committee. A McKinsey team and other ISPE Members representing industry executives and technical experts make up the project leadership teams. ISPE will sponsor a metrics discussion where it will describe the project and solicit input during its 3rd Annual ISPE-FDA CGMP Conference in Baltimore, MD, in early June 2014. Findings of the pilot will be published in the form of papers and educational sessions. Final data and evaluation will be supplied to the FDA and participating companies in aggregate form and will include learnings on feasibility and implementation requirements.

The ISPE PQLI® team will establish a timeline for participation and data collection, to be communicated in the coming weeks. The team anticipates that there will be two "waves" of possible participation: a rapid first wave to establish an initial representative database, and a secondary wave to expand the database across a broader set of industry segments.

If you would like your company to participate in the pilot, please contact, or Vanya Telpis at McKinsey & Company, 973-549-6620,


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