PDA/FDA Joint Regulatory Conference: Proactive CAPA

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On Sept. 9, 2024, Jonathan Chapman, senior policy advisor, Office of Manufacturing Quality Center for Drug Evaluation and Research Office of Compliance at FDA, and Paulien Groll, head of Compliance Excellence at Takeda, gave presentations at the PDA/FDA Joint Regulatory Conference in Washington, DC, discussing corrective actions and preventive actions (CAPA) and quality management.

The terms “proactive” and “prevention-focused” were used in the discussions when talking about adhering to current good manufacturing practices (CGMP). Chapman’s talk stressed that if a facility’s quality system does not address variability in operations in a timely fashion, then there is the potential for lapses in compliance and inconsistent quality (1).

Chapman listed the following key factors for sustainable compliance: effective senior management oversight; proactively identifying and remediating problems before they occur; using quality risk management (QRM) and knowledge management (KM) to make decisions. A “timely and effective escalation process” should be put into place to raise quality problems with senior management, according to Chapman, with a structured approach to management review that results in actions. “Effective management review typically results in the creation of action plans which implement CAPAs and drives continual improvement,” Chapman’s presentation stated (1).

Chapman mentioned the International Council for Harmonisation’s (ICH) Q9 document during the Q&A section of the presentation and stated that FDA sees quality management as mentioned Q9 as “important”. ICH Q9 outlines QRM principles, concepts, and tools and offers applications to aspects of pharmaceutical quality (2). According to Chapman, QRM and KM provide an “early warning system” to support oversight and response to quality risks.

Groll’s presentation focuses on a case study regarding an FDA warning letter Takeda received after an FDA GMP inspection of one of the company’s 30 manufacturing sites (3). Groll detailed how the company performed a “lessons learned” activity to prevent similar results at other facilities. The company identified gaps in the global system or processes that support inspection readiness as well as a lack of a “holistic program” for determining the level of inspection readiness. Takeda took steps to improve its inspection readiness across the company that included an introduction of a global Quality on the Shop Floorprogram, alignment of a global self-inspection program, revised risk-based global auditing, and establishment of an operational compliance team. The operational compliance team created tools, such as a quality management system workbook, standardize response template, standardized presentation formats, and global quality system topic overviews.

During the Q&A session, the importance of testing the effectiveness of a CAPA was raised, with Chapman saying preventive actions should be verified each time. Groll, on the other hand, stressed that this might be too difficult of a task, but it was important to check in on preventive measures.

References

1. Chapman, J. Strategic CAPAs: Beyond Fixes, Expanding Impact Across Operations. Presentation at the PDA/FDA Joint Regulatory Conference, Washington, DC, Sept. 9, 2024.
2. O’Donnell, K.; Kartoglu, U. QRM, Knowledge Management, and the Importance of ICH Q9(R1). Pharmaceutical Technology 2024 48 (7) 20–31.
3. Groll, P. Quality Insights: Proactive Strategies and Preventive Measures for Continuous Improvement. Presentation at the PDA/FDA Joint Regulatory Conference, Washington, DC, Sept. 9, 2024.