Answer:
This question is addressed in the Ph. Eur. General Notices. The test methods analytical procedures 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 these procedures by the analyst user is not required. When implementing a pharmacopoeial method Ph. Eur. analytical procedure, the user must assess whether and to what extent the its 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 . In other words, it is the user’s responsibility of to transfer the userprocedure correctly.
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