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Answer:

As indicated in the General Notices, the analytical procedures 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 users are not required to validate these procedures.

When implementing a pharmacopoeial method, the user Ph. Eur. analytical procedure, users 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 is the responsibility of the user.

In this context, general chapter 5.26. Implementation of pharmacopoeial procedures is published for information. It provides guidance on setting up an approach for the implementation of analytical procedures given in Ph. Eur. monographs. The approach set out in the general chapter is valid only when used in accordance with the principles laid down in the General Notices (including a suitable quality system).

Approaches other than the one described in general chapter 5.26 may also be appropriate to ensure successful implementation. Users are ultimately responsible for the implementation process and its successful outcome needs to be demonstrated and documented to the satisfaction of the competent authority.