Retest Period | PharmaBharat Tools

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Retest Period | PharmaBharat Tools

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RA CMCRetest Period

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Residual Solvent Scale-Up

Retest Period

CMC

Definition

For drug substance, the period during which it is expected to remain within specification and can be retested to confirm suitability for use.

Regulatory source

ICH Q1A(R2), ICH Q1E