Both Agencies acknowledge that when adesign space is established at early stages of product development, it istypically developed based on experiments conducted at laboratory or pilotscale. The confidence in the design space at commercial scale can varydepending on the amount and type of development data generated and theknowledge of the scalability (i.e., the degree of scale dependency of thedesign space). Design space limits at commercial scale can be based on scale-upcorrelations demonstrated during development studies and/or experimentation. Inaddition, design space limits can be challenged with computational simulations.

两家机构都承认，当设计空间在产品开发的早期阶段建立时，它通常是基于在实验室或中试规模进行的实验而开发的。对商业规模的设计空间的信心可能会因生成的开发数据的数量和类型以及对可放大性的了解（即设计空间的规模依赖性程度）而有所不同。商业规模的设计空间限制可以基于在开发研究和/或实验期间证明的放大相关性。此外，设计空间限制可能会受到计算机模拟的挑战。

The Agencies further acknowledged that thecommercial process is generally operated in a specific area of the designspace, sometimes called the NOR (Normal Operating Range). The NOR describes a regionaround the target operating conditions that contains typical operationalvariability. Initial process verification often occurs solely within the NOR atcommercial scale.

两家机构进一步承认，商业化工艺通常在设计空间的特定区域中操作，有时称为 NOR（正常操作范围）。 NOR描述了包含典型操作可变性的目标操作条件周围的区域。初始工艺验证通常仅在商业规模的 NOR 内进行。