In 2017, the board of the ECA Foundation's Analytical Quality Control Group (AQCG) has decided to strengthen the lifecycle approach for analytical procedures. Therefore, the Group developed a new guideline on "Analytical Procedure Lifecycle Management".
The draft for this guideline was discussed with the participants of the Analytical Procedure Lifecycle Management Conference on 23/24 November, 2017 in Vienna. The conference objective was to collect proposals and suggestions for the final version of this guideline. Meanwhile, the ECA QC Group has considered the received suggestions and implemented them as far as possible.
The AQCG is currently in the process of finalizing the final Version 1.0.
In this comprehensive Analytical Procedure Lifecycle Management guideline, the following points are presented and discussed:
The final Version 1.0 of this guideline will be presented at the ECA APLM Workshop on 20 November 2018 as part of the PharmaLab Congress 2018 in Düsseldorf/Neuss in Germany. Each participant will receive a copy of this important new APLM document, and thereby an important tool for implementing a lifecycle approach to analytical development in one's own company.