Is your company’s quality management system (QMS) proactive or reactive? Does your company use data, predictive analytics, statistics, process capabilities, and other tools to help reduce quality anomalies that in the past have led to complaints and other issues? Or does it only react and make changes to the QMS when issues and crises arise?

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FDA’s Quality Maturity Model (QMM) program looks at various factors in a company and how the firm administers and updates its QMS. The QMS is a collection of business processes necessary to consistently implement and maintain quality of product in the marketplace. It is not specific to drugs.

Less mature quality management systems are generally reactive. They look back. They collect general or non-specific metrics about their processes and are primarily aimed at simply achieving compliance with CGMP.

Stronger, more mature quality management systems identify sustainable compliance by focusing on performance and continual improvement and linking the metrics that measure what success and improving on success looks like and that are tied to the patient. At PharmaLink 2021 co-sponsored by FDA and Xavier Health, Perrigo Corporate Quality Systems Senior Director and International Society for Pharmaceutical Engineering (ISPE) Advancing Pharmaceutical Quality (APQ) team chair Tami Frederick reviewed an effort being facilitated by ISPE aimed at helping companies achieve quality management maturity.

[Author’s Note: For background and a review of the FDA QMM program as explained by FDA CDER Office of Pharmaceutical Quality (OPQ) Office of Policy for Pharmaceutical Quality (OPPQ) Director Ashley Boam, click here.]

Advancing Pharmaceutical Quality

The ISPE APQ program is an industry-led effort that seeks to help companies understand the state of pharmaceutical quality within their company. It is based on the ICH Q10 framework, and ties in Product Quality System (PQS) effectiveness elements and enablers, Frederick explained.

She noted that the goals of the effort are to provide and support industry, incentivize sustained, continual improvement in each company’s PQS, and allow for benchmarking.

“This will help to increase the reliability of supply for our patients and for the consumers of our products,” she said. “It also provides better insight for health agencies like FDA and MHRA, who have been involved in these programs and have provided great feedback. They have helped us to assess the program and to make sure that it aligns with the Quality Management Maturity program overall.

The APQ framework (Figure 1) involves a circular pattern consisting of the following steps:

  • Assess quality maturity and align it within the quality management areas
  • Understand the current position
  • Aspire to improve
  • Make improvement actions based on metrics provided by the APQ program
  • Repeat the cycle to continually improve quality maturity
Figure 1 APQ Framework
FIGURE 1 | APQ Framework

Frederick explained that both St. Gallen University and Dun and Bradstreet studies helped inform the design and the processes that were used.

ISPE PQLI Combines the Pieces

ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative was created to provide guidance on implementation of the concepts described in ICH guidelines, focusing on Q8, Q9, Q10, Q11, and Q12. The effort aims to help ensure product quality throughout a product lifecycle, leading to continuous product improvement.

Frederick noted that included in this effort are “Good Practice Guides” that can be used to aid in quality maturity assessment by tying together four core areas of the assessment (Figure 2).

ISPE Advancing Pharmaceutical Quality Program
FIGURE 2 | ISPE Advancing Pharmaceutical Quality Program

“The first one is fully published,” she said—Corrective and Preventive Actions. The second two are being finalized—Management Responsibilities and Management Review, in which two ICH elements have been combined. Also being finalized is the guide on the Change Management System.

In development are guides for the Process Performance and Product Quality Monitoring rubric for Maturity Assessment. “This will be a full Quality Management Maturity Assessment Program that the industry can take, can use themselves, can improve on themselves, and really help themselves to advance and move forward as well,” Frederick emphasized.

The program has been reviewed within industry by many experts and by FDA, MHRA, and several other health authorities, as well as by St. Gallen University and Dun and Bradstreet as well.

“We have had a lot of great feedback from many different expert teams to make sure that we are aligning a program that can work for industry—that can be developed for industry and used within industry,” she concluded.

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