Do European Pharmacopoeia methods need to be validated by the user?

The test methods and procedures specified in the substance monographs are validated as part of the elaboration of the monographs.The methods of the Ph. Eur. are therefore accepted as validated by the European regulatory authorities, so that a reference to the relevant monograph is sufficient. Additional validation by the user is only necessary if this is expressly required in the text.

[GMP Compliance Adviser, Chapter 14.K.4]