(New 17/07/2024) Are analytical procedures appended to a CEP considered equivalent to a European Pharmacopoeia monograph method?

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Answer:

Analytical procedures which are appended to a CEP are not equivalent to European Pharmacopoeia monograph methods but are additional procedures which are necessary for the control of the quality of the substance. Validation data for these procedures is submitted in the CEP application and is assessed by EDQM.