The client was a large pharmaceutical company who had developed a new hybrid drug/device product. A new manufacturing facility was under construction for commercial production. The client had earned a reputation for the high quality and safety of its products, and upholding this reputation was essential to their continued success.
The client had invested in highly complex automated equipment for the new facility, and established a rigorous validation approach based on the GAMP5 equipment lifecycle model. Certain of the equipment performed critical machining and inspection operations with tolerances in the tens of microns, and technically-savvy validation engineers were needed to lead the validation effort.
CKC supplied a team of three senior validation engineers, with technical backgrounds in controls and mechanical engineering. The team quickly assessed the function and criticality of each machine in the client’s overall manufacturing process, and worked with the client’s technical experts to establish user requirements and functional specifications. CKC Automation then generated and garnered approval for the remaining validation deliverables, including risk analyses, procedures, and installation / operation / and performance protocols and reports. Throughout the project, CKC maintained a project schedule and coordinated with the client to ensure availability of required material, personnel, and other resources.
The team’s prior experience in risk-based validation allowed for timely project execution with minimal oversight from the client. CKC Automation’s technical expertise enabled the validation effort to stay tightly focused on those aspects of the machines with impact to product quality and safety, thus maximizing the client’s return on investment.