QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We Work

[...] particularly those who actually determine the design space, it means familiarity with the advanced statistical methods that are used to map the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy, and to determine the various permutations of critical input variables that will keep the product within specifications. SUMMARY It is precisely because biological processes involve many raw materials, numerous upstream and downstream processing steps, numerous types of equipment and operating conditions, and high levels of variation that the analytical and statistical rigor of QbD are required for designing highly robust and reliable systems.