1 回答
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。