Do I need to validate an analytical procedure that is published in the Ph. Eur.?

Answer:

This question is addressed in the Ph. Eur. General Notices. The analytical procedures given in monographs have been validated in accordance with accepted scientific practice and recommendations on analytical validation. Unless otherwise stated in the monograph, validation of these procedures by the user is not required. When implementing a  Ph. Eur. analytical procedure, the user must assess whether and to what extent its suitability under the actual conditions of use needs to be demonstrated according to relevant monographs, general chapters and quality systems. In other words, it is the user’s responsibility to transfer the procedure correctly.