Quality: specifications, analytical procedures and analytical validation

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The European Medicines Agency’s scientific guidelines on specifications, analytical procedures and analytical validation help medicine developers prepare marketing authorisation applications for human medicines.

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.

Specifications

Guidelines


Reflection papers


Analytical validation

Guidelines


Other

Guidelines

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