9/10 May 2023
A new Ph. Eur. chapter 5.26. Implementation of pharmacopoeial procedures has been proposed in Pharmeuropa 32.4. The comment deadline is 31 December 2020.
According to the draft chapter, "implementation of a pharmacopoeial procedure is the process of demonstrating its suitability and applying it under the actual conditions of use in the implementing laboratory".
Pharmacopoeial procedures have been validated in accordance with the relevant guidelines (e.g. ICH Q2) on analytical procedure validation (see Ph. Eur. General Notices). Therefore, validation is not required when implementing these procedures. However, "the user must assess whether and to what extent the suitability of the pharmacopoeial procedure under the actual conditions of use needs to be demonstrated in compliance with relevant monographs, general chapters and quality systems".
The draft Ph. Eur. chapter 5.26 proposes a 2-Step Implementation Process:
More information can be found on the Pharmeuropa website and in the EDQM Newsroom.