ICH: quality

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The European Medicines Agency publishes guidelines on the quality of medicines that are harmonised between Europe, Japan and the United States of America by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

 
Stability

 
Analytical validation

 
Impurities

 
Regulatory acceptance

 
Quality of biotechnological products

 
Specifications

 
Good manufacturing practice

 
Pharmaceutical development

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