可以将两种具有非常相似特征但来自两种不同制造工艺的纳米形态报告为一种纳米形态吗？

可以将两种具有非常相似特征但来自两种不同制造工艺的纳米形态报告为一种纳米形态吗？

Can two nanoforms with very similar characterisers but from two different manufacturing processes be reported as one nanoform?

对于特定的纳米形态，仅允许因批次间差异而导致纳米形态特征的变化（问答 1678）。但是，由于不同的制造工艺可能会产生具有几乎相同特征的纳米形态，因此，只要满足明确的条件，这些不同的纳米形态可以作为一组相似纳米形态的一部分进行注册：注册人报告了属于该集合的纳米形态特征参数的明确界限；注册人证明可以联合进行纳米形态的危害、暴露和风险评估。该证明由该集合中纳米形态的支持数据证实。有关更多详细信息，请参阅问答 1681。

Only variations in nanoform characterisers arising from batch-to-batch variability are allowed for a particular nanoform (Q&A 1678).  However, as different manufacturing processes may result in nanoforms with almost identical characterisers, these different nanoforms can be registered as part of a set of similar nanoforms, provided that explicit conditions are meet:   The registrant reports clearly defined boundaries in terms of characterisation parameters of the nanoforms, which are part of the set The registrant justifies that the hazard, exposure and risk assessment of the nanoforms can be performed jointly. This justification is substantiated by supporting data on the nanoforms in the set. For more details, see Q&A 1681.