How can a design space beverified at commercial scale for biological products? - 分享质量人的知识和经验

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How can a design space beverified at commercial scale for biological products?

EMA

How can a design space beverified at commercial scale for biological products?

如何在生物产品的商业规模上验证设计空间？

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kk444555 一阶会员用户来自于: 广东省深圳市
2023-10-17 23:00

Principles laid down for chemical productsare applicable to biological products. In addition, verification studies shouldprovide evidence that the quality attributes of the product are comparableprior to and after the change. This could include a proposal for modular setsof tests and acceptance criteria to be deployed, taking into account the natureof the change and its associated risk.

为化学产品制定的原则适用于生物产品。此外，验证研究应提供证据证明产品的质量属性在变更前后具有可比性。这可能包括对采用的模块化检测和验收标准的提议，同时考虑到变更的性质及其相关风险。

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发布时间: 2023-10-17 23:00

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