In principle, a design space verificationprotocol could include the following: list of scale dependent parameters whoseimpact on the CQAs has not been verified at commercial scale, definition of thepotential scale-up risks to the CQAs, discussion of whether the controlstrategy can address these risks, and description of any additional controls,as needed.

原则上，设计空间验证方案可以包括以下内容：对 CQA的影响尚未在商业规模上得到验证的规模依赖性参数列表、对 CQA潜在放大风险的定义、控制策略是否可以讨论解决这些风险，并根据需要描述任何额外的控制措施。

EU authorities’ expectation is that aprotocol for design space verification be submitted in section 3.2.R of theapplication. At the time of submission, a proposed design space not verified atcommercial scale should be accompanied by an appropriate verification protocol.The protocol would be assessed at the time of review. Verification data aremanaged and documented in the site change management system.

欧盟当局的期望是在申请的第 3.2.R 节中提交设计空间验证方案。在提交时，未经商业规模验证的提议设计空间应附有适当的验证方案。该方案将在审查时进行评估。验证数据在现场变更管理系统中进行管理和记录。



FDA’s expectation is that any plans fordesign space verification be available at the manufacturing site as an elementof the change control, validation, and/or knowledge management strategy. Providingdata for initial design space verification and a high-level overview of theplan for design space verification over the product life cycle can bebeneficial to the review of the application.

FDA 的期望是任何设计空间验证计划都可以在生产现场获得，作为变更控制、验证和/或知识管理策略的一个要素。为初始设计空间验证提供数据以及在产品生命周期内对设计空间验证计划进行高水平概述可能有助于审查申请。