It goes without saying that assuring quality is a primary responsibility of all parties in the biopharmaceutical supply chain. Drug manufacturers, ancillary material producers, and equipment suppliers must work in harmony to deliver high quality, safe and efficacious products to the market.
Drug manufacturers and their suppliers should have easy-to-use quality management systems in place, working to create a culture driven by quality. Data should go beyond regulatory compliance requirements to include documentation confirming that all components and methods used in drug manufacturing—as well as the controls used to ensure process and product quality—are appropriate and adequate to preserve drug composition, quality, and purity.
Find out more about this fully validated solution to support a Quality by Design approach to single-use assembly design and production. It ensures the delivery of high-quality, fit-for-purpose, single-use systems with strong documentation packages.