5/6 October 2022
Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures (Ph. Eur. 11.0), the EDQM published some examples. The intention is to provide users with practical guidance on how critical factors potentially affecting the Analytical Procedure Performance Characteristics (APPCs) can be identified. However, it is emphasized, that the pre-requisite for the implementation of any analytical procedure is a suitable quality system, which ensures that the requirements set for personnel, premises, and equipment are fulfilled.
The following six examples are provided for the assessment of critical factors associated with the analytical procedure under actual conditions:
More information is available in the Examples of implementation of pharmacopoeial procedures according to Chapter 5.26 "Implementation of pharmacopoeial procedures” published in Pharmeuropa Online under Technical Information.