Q3B(R2): Impurities in New Drug Products (Revised Guideline)

Regulatory Resource: Q3B(R2): Impurities in New Drug Products (Revised Guideline)

Description:

This guideline has been revised and finalised under Step 4 in February 2003. It complements the guideline on impurities in new drug substances and provides advice in regard to impurities in products containing new, chemically synthesized drug substances. The guideline specifically deals with those impurities which might arise as degradation products of the drug substance or arising from interactions between drug substance and excipients or components of primary packaging materials. The guideline sets out a rationale for the reporting, identification and qualification of such impurities based on a scientific appraisal of likely and actual impurities observed, and of the safety implications, following the principles elaborated in the parent guideline. Threshold values for reporting and control of impurities are proposed, based on the maximum daily dose of the drug substance administered in the product.

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

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