We kicked off our series on the Future of GCP with an examination of the history of quality, starting with its roots in manufacturing via Taylorism, statistical process control, the quality cycle, and Total Quality Management. We glimpsed the birth of the management consultant class via The Quality Handbook and Lean Six Sigma. We looked at the standards that gave rise to the modern pharmaceutical quality management system with ISO and ICH Q10. We considered GCP regulatory requirements for quality and contemplated how different clinical trials are from drug manufacturing. This led us to a lengthy consideration of our current quality management system and how well it serves GCP, including SOPs, vendor qualification, training, CAPAs, risk management, and audits.
At last, we're ready to tackle the future of GCP QA. And, no - it's not AI.
The GCP Quality Assurance Lead of the future will be uniquely positioned to help clinical research staff design quality management systems that meet GCP requirements - not GMP requirements. As we learned, there are no GCP requirements for an independent quality unit, vendor qualification audits, "reference" sections in SOPs, or a host of other steps we take for granted as part of a GXP quality management system. This doesn't mean we won't have these things, but when we do, it will be because they help our organization meet GCP - not because we're afraid NOT to do what our GMP colleagues are doing.
The GCP QA Lead of the future will be an expert in these key GCP concepts:
- Risk-Based Approach. GCP QA should, above all, be experts in risk assessment. We should understand how to identify conditions that elevate risks, how to articulate risks, and how to evaluate the costs and benefits of mitigations, and we should apply that knowledge to every part of the quality management system: SOPs, training, vendor qualification, audits, and CAPAs. Continuous risk assessment is a tremendous amount of work as well as a huge departure from how we currently approach quality management. As complexity grows, human nature prompts us to try to exert more control, and with control comes standardization. A risk-based approach requires adequate control but less standardization, as every control is tailored to the risk of the situation. The GCP QA Lead of the future must make a case for the regulatory basis for such an approach and also be an expert in how to apply risk-based approaches efficiently. That brings us to our second key principle.
- Quality. "Quality" means "fit for purpose" or "meeting requirements." To have quality, then, we must have a written requirement and proof that the task was undertaken according to the requirement. When study tasks are tailored using a risk-based approach, quality is frequently the first casualty. As studies become more complex, it's difficult to document so many procedures and so much activity. The GCP QA Lead of the future must be an expert in process development and documentation so we can help our teams achieve quality efficiently.
- Oversight. How do we verify that requirements are established and adherence to requirements is documented? Oversight. The GCP QA Lead of the Future uses auditing expertise to help study teams plan and execute oversight strategies that allow teams to verify quality.
- Record Integrity. The GCP QA Lead of the Future is not only promotes ALCOA+ principles; they are expert in software validation and record management techniques that help ensure integrity.
- Participant Protection. The GCP QA Lead of the Future helps study teams connect risk-based thinking, quality processes, oversight, and record integrity to participant protection.
In practice, what does this look like? Hypothetically, the GCP QA Lead of the future might...
- Show functional leaders how to write short, simple SOPs that adequately cover key steps required for quality.
- Make recommendations on how to streamline study-specific plans to eliminate conflicts and ambiguity.
- Advocate for expansion of the company's Learning Management System to support study-specific training after noting the risk presented by gaps in training documentation.
- Recommend foregoing a vendor qualification audits in favor of enhanced oversight techniques that include review of work product plus short, focused in-process audits.
- Coach a study team on how to conduct a QC review of a Trial Master File.
- Advise teams on how (and why) reviewing audit trails can help ensure data integrity.
- Develop a risk assessment process that captures discussion and mitigation planning with minimal effort.
- Help develop a process to develop focused but robust User Acceptance Test plans and documentation without a lot of effort.
- Highlight an elevated risk inherent in a change to an IRT system and prompt the team to think through potential impacts and mitigations.
Photo by Delorean Rental on Unsplash.
