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".
Validation is not required
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".
2-Step Implementation Process
The draft Ph. Eur. chapter 5.26 proposes a 2-Step Implementation Process:
1) Assessment: Identification of critical factors related to implementation. If no factors are identified as critical, the procedure may be used without any specific verification experiments.
2) Evaluation of method performance characteristics: Verification of selected performance characteristics based on the intended purpose. The verification is used as the second step to evaluate the analytical procedure performance characteristics (APPCs) such as accuracy and precision. The procedure may be used provided that any critical APPCs have been verified to demonstrate the suitability of the procedure under the actual conditions of use. A verification plan should comprise the experiments performed to verify critical APPCs together with the corresponding acceptance criteria.