Q6A: Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances

Regulatory Resource: Q6A: Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in October 1999. This addresses the process of selecting tests and methods and setting specifications for the testing of drug substances and dosage forms. Account has been taken of the considerable guidance and background information which are present in existing regional documents.

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