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Answer:

Alternative methods can be used for in-house control, provided they have been shown to be equivalent to the official ones in the monograph. Alternative methods should be described and their validation stated in the dossier: they will not be attached to the CEP if those of the monograph are appropriate.

However, applicants are reminded that, in case of doubt or dispute, the methods of the monograph are alone authoritative.

For more information, see How to read a CEP (PA/PH/CEP (15) 31).

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