1 回答
FDA recommends that firms have a writtenplan for when and how to evaluate the need for design space verification undertheir pharmaceutical quality system. FDA’s expectation is that such plans for designspace verification be available at the manufacturing site. Additionally, it canbe beneficial to the review of the application for the applicant to include inthe initial submission a high-level overview of the plan for design spaceverification over the product life cycle.
FDA 建议公司制定书面计划，以说明何时以及如何在其药品质量体系下评估设计空间验证的需要。FDA的期望是在生产现场提供此类设计空间验证计划。此外，对于申请人的申请审查，在最初提交的申请中包含产品生命周期内设计空间验证计划的高级概述可能是有益的。
