Do I need to validate a method that is published in the Ph. Eur.?

This question is addressed in the Ph. Eur. General Notices. The test methods given in monographs have been validated in accordance with accepted scientific practice and current recommendations on analytical validation. Unless otherwise stated in the monograph, validation of the test methods by the analyst is not required. When implementing a pharmacopoeial method, the user must assess whether and to what extent the suitability of the method under the actual conditions of use needs to be demonstrated according to relevant monographs, general chapters and quality systems; i.e. the correct method transfer is the responsibility of the user.