Q3A(R2): Impurities in New Drug Substances (Revised Guideline)

Regulatory Resource: Q3A(R2): Impurities in New Drug Substances (Revised Guideline)

Description:

First Recommended for Adoption at Step 4 of the ICH Process on 30 March 1995, the guideline was revised under Step 2 of the ICH Process on 7 October 1999 and Recommended for Adoption under Step 4 on 7 February 2002 by the ICH Steering Committee.

The guideline addresses the chemistry and safety aspects of impurities, including the listing of impurities in specifications and defines the thresholds for reporting, identification and qualification. The revision of the guideline has allowed clarifying some inconsistencies, to revise the decision tree, to harmonize with Q3B and to address some editorial issues.

The Attachment 2 of this guideline has been revised under Step 4 without further public consultation on 25 October 2006.

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