ISPE’s Advancing Pharmaceutical Quality Program Progresses

The second guide in the series, Management Responsibilities and Management Review, is scheduled to be published in summer 2021. The material for the third guide, Change Management System, has been developed and is undergoing industry testing. It is expected to be published at the end of 2021. The team developing the material for the fourth guide, Process Performance and Product Quality Monitoring (PP&PQM) System, has commenced work. There is the exciting prospect that opportunities will be taken to build in maturity of digitization by including ISPE members who are intimately familiar with digitization possibilities proposed in ISPE’s Pharma 4.0® program.

An article was published in the January/February 2012 issue of Pharmaceutical Engineering® describing how the APQ Program has been built and summarizing the content covered in the Advancing Pharmaceutical Quality Guide series, using the CAPA guide as an example. An iSpeak Blog published in October 2020 focused on the rationale and benefits of the APQ Program. Both articles describe the goals, objectives and benefits of the APQ Program with the benefits summarized in Table 1.

The article ad blog discuss APQ’s links to ICH Q10, Pharmaceutical Quality System and to ISPE’s Cultural Excellence work. Notably, and as shown in Figure 1, the concepts, principles, and tools given in ISPE’s cultural excellence work are embedded into the APQ Assess, Aspire, Act and Advance (AAAA) framework.

The extended model shown in Figure 1 indicates other important initiatives. The University of St. Gallen has worked over many years in the field of Operational Excellence (OPEX) and in recent years has collaborated with ISPE in development of the APQ Program. This fruitful collaboration has led to incorporation of the St. Gallen concise, user-friendly OPEX benchmarking module as an option in the APQ Program.

ISPE has had a very active Knowledge Management initiative with the team recently publishing the ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry. This Guide will be an excellent complementary resource to the ISPE APQ Program.

ISPE has continued its Cultural Excellence work leading to a supplement to the 2017 Cultural Excellence report being produced on Reward and Recognition and best practices for conducting a GEMBA Walk. There are many references in the APQ Guides to potential cultural excellence assessment and improvement activities, which are practical and realistic. There is the prospect that all this Cultural Excellence work will be consolidated as another Guide in the APQ Guide Series.

FDA has also shown considerable interest in quality management maturity. In 2018 and 2019, the FDA drew from St. Gallen research as the agency started to discuss the concept of quality maturity in public presentationsMullin, T. “Center Update: CDER.” Presented at the 24th Annual GMP by the Sea Conference, Cambridge, Maryland, 12 August 2019. leading to an extensive discussion on quality management maturity in the FDA report, Drug Shortages: Root Causes and Potential Solutions.

In fall 2020 FDA announced a quality management pilot program.Federal Register Notice, October 16, 2021, Quality Management Maturity for Finished Dosage Forms Pilot Program (QMM FDF Pilot Program) -open to domestic manufacturers of drug products marketed in the USDocket No. FDA-2020-N-2031^,Federal Register Notice, October 16, 2021, Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program (QMM API Pilot Program) -open to foreign manufacturers of API used in drug products marketed in the USDocket No. FDA-2020-N-2018^,FDA Webinar, November 12, 2020, slides https://www.fda.gov/media/143742/download Through this pilot program, a third-party contractor identified by the FDA will conduct an onsite assessment of a facility’s quality management system, accompanied by FDA staff. The Agency will gain insight from the results of the Quality Management Maturity (QMM) assessments to inform the development of a framework for conducting QMM assessments of manufacturers and a rating system that will incentivize industry investments in quality management maturity. Participation is voluntary and the participating sites will be able to use assessment information in their continual improvement efforts.

ISPE believes that the APQ AAAA framework should assist with the challenge of assessing quality management maturity.

Conclusion

Significant progress has been made with the ISPE APQ quality maturity management program, Advancing Pharmaceutical Quality with the real prospect that the complete program will be available in mid 2022.

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