New Ph. Eur. Chapter on Implementation of Pharmacopoeial Procedures

Ph. Eur. 11.0 has been published in July 2022. Amongst others, the 11th Edition contains the previously announced new general chapter 5.26. Implementation of Pharmacopoeial Procedures. The text will be implemented on 1 January 2023. In addition, a draft for an additional new chapter 5.27. Comparability of alternative analytical procedures has been published for comment this year.

Two-Step Process

Pharmacopoeial procedures have been validated. Therefore, unless otherwise stated, 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 conditions of use needs to be demonstrated.

According to the Ph. Eur., "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". The new general chapter provides guidance on setting up an 2-step approach for the implementation of analytical procedures given in monographs of the Ph. Eur. (= pharmacopoeial procedures). The term implementation is used to describe the overall activities performed, whereas verification is used exclusively to refer to the experimental activities. The 2-step approach includes the following:

• The first step of the implementation process is an assessment to determine whether there are any factors associated with the complexity of the procedure and the conditions of its use in the implementing laboratory that may affect the performance of the procedure.
• If such factors are identified, an experimental verification is the second step to evaluate the analytical procedure performance characteristics (APPCs), e.g. accuracy and precision.

The implementation process is the user’s responsibility and its successful outcome needs to be demonstrated and documented to the satisfaction of the competent authority. The publication of a revised monograph requires re-evaluation of the implementation of the concerned analytical procedure.