FDA对制剂颜色和包衣颜色变更的说明

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普通制剂扩大规模或上市后变更指导原则有关事项的问题和解答
& m% y8 e  A6 I5 N8 c/ SSUPAC-IR Questi** and Answers about SUPAC-IR Guidance

1.

Q: May one color be replaced with another by placing the batch on concurrent stability and reporting it in the annual report?

A: A change from one color to another should be submitted as a prior approval supplement.

2.

Q: Can color be changed under SUPAC-IR?

A: Yes. A change in color, either in amount or from one color to another, is a level 3 component and composition change which calls for a prior approval supplement. However, if the color is merely being removed, it is a level 1 change and can be reported in the next annual report.

1.

问题： 能否通过将该批号放在当前的稳定性研究中，并在年度报告中报告的做法将一种颜色以另一种颜色代替?

回答：从一种颜色改为另一种颜色应当按Prior approval supplement申报。

2.

问题： 颜色能否按SUPAC-IR更改？

回答：可以。颜色的更改，不论是量的变化还是由一种颜色改为另一种颜色，都属于成分和组成的3级变更，需要按Prior approval supplement申报。但如果仅仅是去除颜色，则属于1级变更，可以在下一次年度报告中报告。

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