It is not necessary to repeat at commercialscale the experiments initially conducted to define a design space at labor pilotscale. Furthermore, it is neither necessary to verify entire areas of designspace nor to identify the edge of failure. In principle, more than one area of adesign space may be verified at the time of submission but the design spacecan, as appropriate, also be further verified over the product lifecycle.

没有必要在商业规模上重复最初进行的实验室规模或中试规模的设计空间的实验。此外，既不需要验证设计空间的整个区域，也不需要识别失败边缘。原则上，可以在提交时验证设计空间的多个区域，但也可以酌情在产品生命周期内进一步验证设计空间。

The approach to design space verificationover the product life cycle can be guided by the results of risk assessment onthe potential effect of changes to scale dependent parameters on productquality.

在产品生命周期内进行设计空间验证的方法可以由风险评估结果来指导，该风险评估结果是关于规模依赖性参数变更对产品质量的潜在影响。

Depending on the specific change, thepotential impact to the product quality, and the ability of the controlstrategy to detect product failures, the management of the risk can include additionalmonitoring of quality attributes and/or process parameters not included in theroutine control system.

根据具体的变化、对产品质量的潜在影响以及控制策略检测产品失败的能力，风险管理可以包括对常规控制系统中未包括的质量属性和/或工艺参数的额外监控.