Ensuring Quality & Compliance: CQV for a Cutting-Edge cGMP Manufacturing Facility
In the fast-paced world of molecular diagnostics and research, precision and compliance are critical. One of our confidential clients, a leader in research and emergency use authorization (EUA) solutions, sought to enhance its operations with a new cGMP manufacturing facility in Irvine, CA. Their innovative technology, capable of detecting hundreds of targets on a single platform, demanded a highly controlled and validated environment. GMC Commissioning was proud to provide turnkey Commissioning, Qualification, and Validation (CQV) services to ensure this facility met the highest standards of regulatory compliance, efficiency, and quality.
The new facility included state-of-the-art ISO-8 clean rooms, research and development laboratories, office space, GMP warehouse, and advanced cold storage systems. From the outset, our team was involved in the Design Development (DD) phase, conducting a thorough peer review of the MEP system designs and developing the Basis of Design (BOD) for the validation Environmental Monitoring System (EMS).
Our role extended beyond standard commissioning, as we collaborated closely with the client to implement a risk-based CQV strategy, ensuring an efficient and streamlined testing schedule while maintaining strict adherence to industry regulations. Throughout the project, our expertise in compliance was critical in guiding the client through ISO-13485 standards, including developing standard operating procedures and identifying potential gaps in internal processes—key considerations for future FDA audits.
To support the facility’s rigorous performance requirements, GMC Commissioning led the development and execution of comprehensive validation plans, including the Validation Master Plan (VMP), Commissioning Plan, and User Requirements Specifications (URS). Our team also managed equipment calibrations, certifications, and the commissioning and qualification (Cx/IOPQ) protocols to confirm that all systems met operational and regulatory expectations. The qualification process covered critical environmental and equipment systems, including clean rooms, warehouses, controlled temperature units (CTUs) such as fridges and freezers, incubators, walk-in cold rooms, and bio-safety cabinets (BSCs). Each component played a crucial role in maintaining the facility’s strict environmental controls and ensuring product integrity.
Challenges & Lessons Learned
As with any complex facility, unexpected challenges arose that required quick thinking and problem-solving. One major issue emerged with automated defrost cycles in validated fridges and freezers, which led to temperature excursions beyond tolerance limits. By identifying these fluctuations during the Operational Qualification (OQ) phase, our team worked with the client to modify equipment use and setpoints, ultimately preserving the stability of temperature-sensitive materials. Another significant challenge involved systemic leakage in clean rooms during HEPA filter testing. Despite confirming the integrity of filters, gel seals, and fan filter units, leakage persisted. Further investigation revealed the culprit: air escaping through ductwork and being forced into clean rooms via ceiling tiles. To resolve this, we implemented additional sealing of the ceiling grid and enhanced gasketing and clipping of tiles, successfully eliminating the leakage and restoring the required controlled environment.
Driving Innovation Through Quality Commissioning
This project exemplifies how a strategic and meticulous CQV approach ensures compliance, efficiency, and long-term operational success. By integrating peer reviews, validation expertise, and real-time problem-solving, GMC Commissioning played a pivotal role in delivering a fully functional, regulatory-compliant cGMP facility designed to support the client’s groundbreaking molecular research and diagnostics. As the industry continues to push the boundaries of innovation, we remain committed to providing commissioning solutions that safeguard quality, compliance, and performance—empowering our clients to bring critical medical and research advancements to the world with confidence.
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