Quality Metrics Initiative

ISPE has been in the forefront of the quality metrics dialog by hosting FDA and industry forums and workshops, conducting the industry’s first Quality Metrics Pilot Program, and providing input to the FDA draft Guidances based on experiential and objective pilot program data.

Advancing Pharmaceutical Quality

ISPE is fully aligned with FDA’s vision:

A maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.

The ISPE’s Advancing Pharmaceutical Quality (APQ) program proposes an industry-led approach to advance pharmaceutical quality beyond the submission of data for harmonized, reportable metrics. The basic framework of the program is to “assess and aspire” quality maturity.

Quality Maturity Framework

ISPE has started to draft an industry-led Quality Maturity Framework, based on ICH Q10, which could be leveraged by industry and potentially FDA to achieve quality metrics program objectives.

Program goals for the Quality Maturity Framework include:

  • Enable and foster industry ownership of quality beyond compliance
  • Integrate quality, cultural, and operational excellence principles and learnings
  • Support and incentivize continual improvement
  • Promote efficient use of resources by improving execution
  • Increase reliability of supply for quality product
  • Fuel benchmarking, sharing, and learning among companies
  • Provide a program that has value to industry worldwide whether it is adopted by regulators or not
  • Encourage self-improvement and supplier improvement
  • Have potential competitive advantage
  • Have potential for the program to be adopted by regulators, providing additional benefits to industry through regulatory interaction and regulatory relief
  • Foster the principle of collaboration such that:
    • Adjustments and improvements to the program are facile
    • Outcomes and changes are transparent to all involved
Overview of ISPE Quality Maturity Framework
Overview of ISPE Quality Maturity Framework

Guiding principles are:

  • “By industry, for industry,” at least at the outset
  • Must have value and benefits to industry
  • Be seen as attractive to and beneficial for regulatory agencies
  • Be applicable across all sectors of the pharmaceutical industry
  • Use “as-is” company data and site procedures as much as possible
  • Minimize additional work
  • Leverage existing methodologies and principles where relevant (e.g., ISO, VPP, MHRA, ICH Q10)
  • Engage FDA and others in design
  • Complement existing FDA initiatives (e.g., quality metrics, New Inspection, Protocol project, data analytics)
  • Simplicity
  • A major vision of this program is that regulators may become involved in the design of its framework and ultimately adopt and/or evolve relevant parts of the program to help achieve their goals. For example, since the design of the proposed program is based on the ICH Q10 Model, it may assist with providing tools and concepts for the New Inspection Protocol Project (NIPP).
Framework Detail
Framework Detail

For more information, contact regulatory@ispe.org.

Cultural Excellence

The influence of an organization’s quality culture has emerged as a key enabler from the recent public discourse on measuring performance and quality metrics for delivering outcomes that matter to the patient.

Cultural excellence requires that all employees are passionate about eliminating mistakes by making quality their driving principle.  It goes beyond following the content of the quality policies and procedures by creating an environment that is focused on continuous improvement and learning.

Examining the powerful force that culture exerts on day-to-day operations within organizations, ISPE’s Quality Culture Team has established that although for many the concept of quality culture remains abstract, the behavioral impacts are very real indeed.

ISPE’s Cultural Excellence Team has developed a collection of practical, powerful tools and a comprehensive behavior-based approach for improving quality culture as a means of delivering enhanced quality outcomes.

Published 2017, 100 pages
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