Regulatory Readiness: Brevitas’ Targeted Strategies for GMP Qualification of 50+ Benchtop CGT Systems
The Brevitas team developed and executed protocols for the qualification of over 50 benchtop CGT systems for GMP operations. Throughout the process, we provided troubleshooting to address gaps and ensure the successful completion of key qualification milestones. Keep reading to learn more about our team’s strategies for achieving regulatory goals.
Business Challenge
One of Brevitas’ CGT clients faced compliance challenges in qualifying their benchtop CGT systems for GMP operation. Major risks included incomplete URS coverage, DIA gaps, and PQ failures. Seeking to avoid non-conformances, operational inefficiencies, and costly delays, the client called on Brevitas to eliminate gaps and support their efforts towards regulatory success.
Our Approach
The Brevitas team leveraged extensive industry experience, driving a proactive evaluation of business objectives to determine a strategic approach for effectively resolving each challenge:
- User Requirement Specification (URS) Gaps were addressed through a comprehensive evaluation of client needs, production criteria, and equipment capabilities. From this, URS were revised and refined, becoming functional and practical documentation to guide protocol development and optimize the time spent in non-conformance management in qualification.
- Data Integrity Assessment (DIA) Gaps were traced to manual photo entries. To resolve this, Brevitas recommended procedural controls for authenticating images at the time of capture and technical controls to strengthen electronic record integrity, preventing unauthorized modifications and ensuring regulatory compliance.
- Performance Qualification (PQ) Failures were resolved after discovering that subcomponents for essential equipment had been overlooked during machine installation. Their absence impacted overall system performance. Once identified, SOPs were revised to explicitly reference the subcomponents, aligning qualification requirements with the client’s operational practices.
By taking targeted actions, Brevitas ensured that the client’s systems met industry standards while avoiding costly setbacks.
Results Achieved
The Brevitas team contributed to the success of the project, as seen in the following outcomes:
- Delivery of complete qualification documentation for 50+ systems, ensuring regulatory inspection readiness.
- Zero audit findings related to equipment qualification in a follow-up internal audit post-qualification.
- Implementation of a GMP-compliant method for authenticating equipment images.
- Proactive and swift non-conformance management, optimizing timelines for successful execution
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