ICH Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/367/96
Effective from01/05/2000
KeywordsSpecification, active substance, finished product, chemical, control, test, acceptance criteria, limit, release

This document aims to assist in the establishment of a single set of global specifications     for new drug substances and new drug products. It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them. 

It applies to new drug substances and new drug products which have not been registered previously in the ICH regions.

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