White Raven’s journey toward GMP certification is a testament to modern pharmaceutical manufacturing, where agility and cutting-edge technology converge. From the very beginning, the company embraced a digital-first approach, integrating advanced digital tools to fast-track compliance and ensure efficiency at every stage.
A key enabler of this success was the implementation of Cytiva’s SA25 Aseptic Filling Workcell, which provided a fully automated, closed-system solution to significantly reduce contamination risk and be Annex-1 compliant from day one.
As part of its strategy to achieve GMP certification in record time, White Raven implemented a robust electronic Quality Management System (eQMS) alongside scalable ERP and MES platforms.
This integrated approach, with a strong emphasis on regulatory compliance, process development and continuous improvement, enabled the company to introduce automated workflows, real-time monitoring, and comprehensive traceability. These capabilities significantly reduced manual errors, ensured data accuracy, and streamlined compliance efforts, key factors in accelerating the certification process.
The certification process itself was meticulously planned and executed. White Raven prepared mock inspections, document reviews, and staff training to ensure readiness. A structured, two-room approach during the GMP inspection allowed for seamless communication and timely responses to any requests.
Post-inspection, the company demonstrated an extraordinary commitment to continuous improvement by submitting a CAPA plan in just 11 days, expediting the final GMP certification decision.
Through strategic planning, digital transformation, and rigorous process management, White Raven exemplifies how pharmaceutical companies can meet regulatory challenges efficiently without compromising quality or timelines.