1 回答
If the verification studies prove theprocess does not meet the predefined product quality attributes in a new regionof the approved design space, this may indicate an underlying issue with thedesign space or a flaw in the assessment or verification plan. Changes to theboundaries or description of the design space and any required changes todesign space verification protocol should be reported to the Agencies, usingappropriate notification categories, in accordance with regional requirements.
如果验证研究证明该工艺在批准的设计空间的新区域中不满足预定义的产品质量属性，则这可能表明设计空间存在潜在问题或评估或验证计划中存在缺陷。对设计空间的边界或描述的变更以及对设计空间验证方案的任何所需变更都应根据区域要求使用适当的通知类别向各机构报告。
Appendix 1 and 2 address regionalexpectations and regulations
Appendix 1: EU’s expectations
附录1和2提出区域期望和法规
附录1：欧盟的期望
