Outcome of the AQCG Board Meeting in November: New Board Member and Approval of the AIQSV Guide

The ECA Analytical Quality Control Group (AQCG) met in-person on 20 November 2023 in Düsseldorf/Neuss, Germany. During this Board Meeting, several decisions were made concerning both the composition of the Board and the work program for the coming months.

Patrick Jackson

Patrick Jackson, Investigator in Chemistry, Manufacturing and Controls - Analytical at GSK, was invited to join the Board and accepted his nomination. 

Patrick joined GSK in 2005 following the completion of his MChem at York University. He joined the Analytical Method Robustness Testing group in 2008, took over leadership of this group in 2012 and oversaw its transition to a general AQBD support group handing on the leadership in 2016. He completed an MSc in Applied Statistics with Sheffield Hallam 2010-2013. Patrick founded and still currently leads the Analytical Quality by Design Community in 2014.

Review and Approval of the Guide to AIQSV

During the Board Meeting, version 1 of the new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV), was adopted.

The ECA has decided to publish the Guide widely by allowing users to download the document free of charge. The PDF file is available in the AQCG members' area. For further information and to apply for a free membership, please visit the group's website.

Work Programm for 2024/2025

The group has agreed, among other things, to include the following elements in the work program for the next two years:

• Review and updating of existing Guidelines, in particular
  - OOS Guideline 2013 following FDA September 2022 update
  - OOE/OOT Guideline 2016 updated for <1220> Stage 3
  - APLM Guideline July 2018 updated for <1220> & Q2(R2) & Q14
• Expanding the AQCG links with authorities and other organizations

About the Group

The ECA Analytical Quality Control Group aims at providing a networking platform for analytical chemists in development and manufacturing, quality control, regulatory affairs and quality assurance professionals in order to facilitate an active discussion of the impact of the latest regulatory changes as well as identifying and addressing technical issues and challenges. In addition, it actively supports a harmonised approach by 

• Providing guidance documents on topics of specific interest to Quality Control,
• Developing discussion/position papers and generic procedures via expert working groups,
• Facilitating an effective and efficient communication between industry, competent authorities and the pharmacopoeias regarding analytical quality control.

For further information and to apply for a free membership, please visit the group's website.