One of the most well-received presentations from Momentum Events’ December 2023 2nd GCP Inspection Readiness Conference was Tony Johnson, Senior Director of Global Quality Assurance at Mallinckrodt Pharmaceuticals. His proactive compliance and quality management expertise shone through as he outlined strategic initiatives to embed quality into the clinical trial process. This article will dive into his insights on clinical trial GCP, QA, and QC.
Striving for Proactive Compliance
Johnson’s presentation underscored the imperative of understanding and implementing ‘quality by design’—a proactive stance that anticipates potential compliance issues and integrates quality measures upfront rather than relying on inspections to trigger quality actions. His objectives were clear: to showcase how recent inspection findings inform quality by design and to discuss proactive measures that not only expedite inspections but may render them unnecessary.
Delineating Quality Assurance and Control
Johnson clarified the definitions of Quality Assurance and Quality Control as per ICH E6 R2, describing QA as a sponsor’s responsibility to formalize quality requirements. He cautioned against the conflation of QA and QC activities, stressing that a holistic approach to quality is often lacking, leading to reliance on QA to identify significant issues and an absence of adequate QC and clinical trial GCP throughout the study.
Recent Regulatory Inspection Findings
Reflecting on recent inspection findings from the FDA and MHRA, Johnson noted major concerns such as inadequate case histories, monitoring deficiencies, and lack of medical oversight. These points underscore the clear need for sponsors to instruct and oversee clinical trials to prevent non-compliance adequately.
Quality Management as a Cornerstone
Johnson detailed how Quality Management should be involved from the protocol’s final draft stage, providing an independent review to ensure clinical trial GCP alignment
between protocol sections and the tangible evidence that will be collected. By joining study team meetings as an advisor and holding routine meetings with the Clinical Operations team, Quality Management fosters a proactive approach, ensuring study conduct is accurately described in marketing applications and preparing for regulatory inspections.
Quality Agreements: A Blueprint for Success
Quality Agreements between sponsors and CROs are pivotal in establishing clear communication and escalation pathways, separate from operational discussions. These agreements outline auditing expectations, handling serious breach concerns, and the support CROs need during inspections.
Functional Review and Adequate Planning
Johnson highlighted the importance of a functional review of CRO/vendor processes and the issuance of detailed monitoring and medical oversight plans. He emphasized the need for clear communication from clinical sites to CROs and Sponsors, which must be well-documented and accessible.
Proactive Auditing and Continuous Improvement
Auditing is integral to quality management, focusing on significant concerns identified through monitoring and QC activities. Johnson pointed out the need for a feedback loop to inform management of concerns and make necessary changes in processes that may not work as intended.
Conclusion: Embracing a Holistic Quality Approach
Tony Johnson showcased the immense value of a comprehensive approach to Quality Assurance, Quality Control, and Quality Management. By building quality into every facet of the clinical trial process, organizations can reap significant benefits, ensuring regulatory compliance, enhancing efficiency, and safeguarding patient safety.
Continue the conversation at the upcoming Clinical Quality Oversight Hybrid Conference in Philadelphia on May 21-23. For more information, go to https://bit.ly/3GNSzGQ and save 15% with the Discount Code CTV15.