Quality Management Maturity Framework - ISPE Advancing Pharmaceutical Quality Team and University of St.Gallen OPEX

ISPE’s Advancing Pharmaceutical Quality (APQ) team and the University of St.Gallen Operational Excellence (OPEX) team have partnered to develop a comprehensive program for assessing and improving an organization’s Quality Management Maturity. ISPE is developing the Advancing Pharmaceutical Quality Assess, Aspire, Act and Advance Framework, a program comprised of quality maturity assessments, key performance indicators (KPIs), and continual improvement tools focused on advancing organizational capabilities across the four ICH Q10 Pharmaceutical Quality System (PQS) elements:

• Process Performance and Product Quality Monitoring System
• Corrective Action/Preventive Action (CAPA) System
• Change Management System
• Management Review

The ISPE Advancing Pharmaceutical Quality Assess, Aspire, Act and Advance Framework will include an integrated Operational Excellence benchmarking and a deep dive quality maturity assessment tool, both of which were developed by the University of St.Gallen, Switzerland.

The Operational Excellence benchmark enhances the ISPE Advancing Pharmaceutical Quality Assess, Aspire, Act and Advance Framework by including a quantitative pre- and post-assessment, sandwiching the deep dive. The Operational Excellence benchmarking can be conducted in the form of an external benchmarking against an appropriate industry peer group from St.Gallen’s Global Quality Benchmarking 2020 study (see below), or as an internal self-evaluation. It offers objective evidence of performance improvement to support ongoing investment of an organization’s time and resources as each Advancing Pharmaceutical Quality and ICH Q10 element is implemented. The effectiveness and impact of the quality management maturity improvements can be evaluated and quantified through this program.

The University of St. Gallen recently launched the Global Quality Benchmarking 2020 study (also referred to as Pharmastudy) in collaboration with Dun & Bradstreet and the US FDA. The study will produce a globally representative baseline data set that characterizes quality management maturity among human drug manufacturers. It strives to analyze quality management maturity and operational data from approximately 2000 manufacturing establishments in 52 countries.

The concise, user friendly benchmarking module in that study was derived from the original St. Gallen Operational Excellence Benchmarking program. All selected Performance Indicators and Enablers are meaningful for understanding overall plant stability and performance. In total, there are 13 Key Performance Indicators (KPIs) in four dimensions, 18 Maturity Questions in three categories and five Contextual Factors that go into the study. Developing this set of measures required extensive research, primarily using St. Gallen’s databases containing operational performance data from more than 380 manufacturing sites and around 100 quality control labs. These databases were built over the last 15 years and contain the outcomes of the full St. Gallen Operational Excellence benchmarking programs. Based on the available data sets, statistical exploration—such as correlation and regression analyses or t-tests—led to the selection of a subset of 13 metrics surrogating overall performance. Additional validation comprising the direct comparison of the new abbreviated overall performance score calculated based on the chosen measures only, and the full performance score used in the legacy benchmarking provides confidence from a system perspective.

The quality maturity benchmarking, part of the Pharmastudy, is the same assessment that will be included in the ISPE Advancing Pharmaceutical Quality Assess, Aspire, Act and Advance Framework.

The ISPE Advancing Pharmaceutical Quality Assess, Aspire, Act & Advance Framework provides, for each Q10 Pharmaceutical Quality System element, practical, diagnostic tools, comprising both quantitative and qualitative criteria, against which pharmaceutical quality system maturity can be evaluated and improved upon. In summary, current quality management performance for each element can be assessed and then objective and measurable goals set in an improvement action plan.

The ISPE Advancing Pharmaceutical Quality Assess, Aspire, Act and Advance Framework has been designed to be:

• An industry-led quality management maturity framework for advancing the state of pharmaceutical quality that companies can leverage to assure a continuous supply of high-quality medicines to patients
• Built upon the quality framework described in ICH Q10 Pharmaceutical Quality System, enhanced to include operational excellence and cultural excellence tools, approaches and behaviors
• Comprised of maturity assessments, key performance indicators (KPIs), and continual improvement tools focused on advancing organizational capabilities across the four Pharmaceutical Quality System elements;
  • Process Performance and Product Quality Monitoring System,
  • Corrective Action/ Preventive Action (CAPA) System,
  • Change Management System,
  • Management Review
• Complementary to current international regulatory initiatives promoting quality excellence

The ISPE Advancing Pharmaceutical Quality Assess, Aspire, Act & Advance Framework is planned to be published as a series of ISPE Guides. The first module, Corrective Action/Preventive Action Systems, is expected to be published in late 2020.

The ability to offer a scientifically conceptualized baselining as well as an opportunity to measure the impact of the application of the Advancing Pharmaceutical Quality deep dives on quality and delivery performance adds significant value to the Advancing Pharmaceutical Quality framework. We are delighted to support industry on its journey to advanced pharmaceutical quality and quality management maturity. Please contact Tami Frederick (Chair ISPE Advancing Pharmaceutical Quality team) for more information on the Advancing Pharmaceutical Quality Program, or Marten Ritz (University of St.Gallen) for participation in the Pharma study.