In this article, Richard Hammond outlines the complexities vendors face when transitioning new life sciences equipment from research use into GMP-regulated manufacturing environments.

The shift demands a fundamental change in processes and mindset, emphasizing risk management, thorough qualification and validation, and strict change control to ensure consistent product quality and compliance. Vendors must understand that while GMP regulations apply to their customers, their equipment and support directly impact their customers’ compliance and business success.

Hammond highlights the importance of embracing risk management across design, manufacture, and support, along with demonstrating equipment fitness through well-documented qualification stages. He also stresses the challenges of computerized system validation and rigorous change control processes required in GMP settings.

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This article is part of our Editorial Coverage series, showcasing Sphere Bio’s thought leadership and technological contributions in top-tier industry publications. Stay tuned for more.