iSpeak Blog

ISPE’s Advancing Pharmaceutical Quality Program Progresses

Tami J. Frederick
Christopher John Potter, Ph.D.
ISPE AAAA Framework

Advancing Pharmaceutical Quality, Corrective Action/Preventive Action (CAPA)ISPE’s quality management maturity program, Advancing Pharmaceutical Quality (APQ) has progressed significantly. The first Good Practice Guide in a series, Corrective Action, Preventive Action (CAPA) was published in December 2020. To assist practitioners, a complimentary webinar, Advancing Pharmaceutical Quality, Corrective Action/Preventive Action (CAPA), to explain the CAPA APQ program is scheduled for Wednesday, 26 May 2021 at 11:00 EST. In addition to ISPE experts, there will be participation from the USFDA and the University of St. Gallen, Switzerland.

ISPE AAAA Framework

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.

Table 1: APQ program benefits.
Beneficiaries Benefits
Industry
  • Access to an ICH Q10–based quality maturity framework that can be used in full by an organization to understand the impact of their quality maturity assessment, KPI application, and improvement actions to the overall performance of the organization
  • Support and incentives for sustained, continual improvement of a firm’s PQS
  • Benchmarking and best-practice sharing to accelerate progress
Patients and consumers
  • Increased reliability of supply of quality product
Health agencies
  • Better insight into the industry’s focus and current expectations regarding critical quality areas for advancing pharma quality
ISPE
  • Source of educational and training materials and ongoing publications
  • Building an APQ good practice community for knowledge sharing and support

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.

Figure 1: APQ Program links to the ICH Q10 PQS Model
Figure 1: APQ Program links to the ICH Q10 PQS Model

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.

Good Practice Guide: Knowledge Management in the Pharmaceutical IndustryISPE 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 presentations1 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.2,3,4 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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  • 1. Mullin, T. “Center Update: CDER.” Presented at the 24th Annual GMP by the Sea Conference, Cambridge, Maryland, 12 August 2019.
  • 2. 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
  • 3. 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
  • 4. FDA Webinar, November 12, 2020, slides https://www.fda.gov/media/143742/download