Input to Regulators

Input to Regulators

ISPE continues to support quality metrics and quality management maturity programs that have value to regulators, industry and patients. ISPE’s input is experiential and data driven, drawn from:

  • A quality metrics initiative spanning more than 4 years and led by a core team and senior leaders representing 10 companies
  • An extensive pilot program conducted in cooperation with McKinsey and Company with participation from 28 companies and 83 sites.  These companies and sites represented a wide range of technologies and included contract manufacturing organizations (CMOs) and laboratories, and drug substance manufacturing sites.
  • Response team of knowledgeable practitioners, 21 members, 12 companies including CMOs and API manufacturers
  • Ongoing robust dialog with pilot companies and the industry at large at ISPE conferences, workshops, and forums

Insights gained over the past four years remain consistent:

  • Definitions and terminology must be exact in order to avoid multiple interpretations by participants, and to enable consistency in reporting and ability to conduct analysis
  • Many companies currently collect metric data at a site level and often utilize definitions different from the FDA or agreed ISPE harmonized definitions. Moreover, there are often different definitions or variations in interpretations of a definition between sites in the same company. Consequently, there is a significant burden for companies to collect data against harmonized definitions.
  • Frequency of data collection (e.g. quarterly, annually) has a major impact; analytic and reporting burden is proportional to the number of data points collected
  • Producing metric data on a product basis is difficult for products manufactured with complex supply chains and for companies with a large number of products. Historically, these data were not commonly produced or included in periodic product reviews (PPRs)

As the public discussion of quality metrics continues, the importance of value relative to the burden is being increasingly recognized. ISPE is uniquely positioned to facilitate the ongoing dialogue between regulators and industry.

Date Dialogue
Nov 2022 ISPE presentation to FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
Jun 2022 ISPE response to FDA Quality Metrics Reporting Program
Oct 2018 ISPE response to FDA Modernizing Pharmaceutical Quality Systems, Studying Quality Metrics and Quality Culture, Quality Metrics Feedback Program
Mar 2017 ISPE response to FDA revised draft Guidance, Submission of Quality Metrics Data
Sep 2016 ISPE response to FDA Quality Metrics Technical Conformance Guide
Nov 2015 ISPE response to FDA draft Guidance, Request for Quality Metrics
Aug 2015 ISPE presentation at FDA Quality Metrics Public Meeting
Dec 2013 ISPE whitepaper: ISPE Proposals for FDA Quality Metrics Program