ICH Q11 Development and Manufacture of Drug Substance
ICH Q11 Development and Manufacture of Drug Substance
5 Selection of Starting Materials and Source Materials
■ 6 general principles for consideration
■ All general principles should be considered rather than
strictly applying each general principle
General principles paraphrased
1. Changes within early steps of a given synthesis lower potential impact on API
Describe enough so that reviewer can understand where and how impurities in
the API are formed and why proposed Control Strategy is suitable
2.
4.
5.
Steps impacting impurity profile should normally be included
Each branch of a convergent synthesis begins with one or more starting
material
Substance with defined chemical properties and structure - usually isolated
6. Significant structural fragment
Example 4 clarifies how to use these principles
March 2012
ICH
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