ISPE Quality Metrics Pilot Program Proceeding as Planned
ISPE will conduct the industry’s first Quality Metrics Pilot Program. 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). The ISPE Product Quality Lifecycle Initiative (PQLI®) Metrics Team will provide overall project oversight supported by the ISPE Board of Directors and the full PQLI Committee.
The pilot will be open to a limited number of sites and will include data from multiple product types, e.g., solid orals and sterile, as well as represent branded, generic and OTC products. This sample set will ensure statistically meaningful findings. The pilot also will take into account a sampling from large molecule sites to test the feasibility and applicability of data definitions and collection.
To assure participating companies of complete confidently, an independent third party, McKinsey & Company, has been contracted to collect and analyze the plant-level data. McKinsey will enter into a confidentiality agreement with each participating company and will establish a confidential database to be used only for this pilot. McKinsey will report blinded industry-level analyses to the ISPE PQLI® Team and to participating companies in order to inform pilot analyses and recommendations. McKinsey also will report individual company results back to the respective companies, along with comparisons to the full industry-wide pilot sample. McKinsey will charge participating companies a fee to cover data collection and analyses.
The ISPE PQLI® Metrics Team will publish findings of the pilot in the form of papers and educational sessions, including their learnings on feasibility and implementation requirements. Information from the pilot also will be shared with the FDA in aggregate form.
A timeline for participation and data collection will 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.
More information will be posted here as it becomes available. For any other inquiries or to express your company’s interest in participating, you may contact PQLI@ispe.org or Vanya Telpis at McKinsey & Company, 973-549-6620, firstname.lastname@example.org .