Conference: Analytical Quality and Lifecycle Concepts

A Track Organised by the ECA Analytical Quality Control Group

25 November 2025

Background & Objectives

The ECA Analytical Quality Control Group (AQCG) 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.

The AQCG actively promotes harmonisation 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

One recent result of this work is the new Laboratory Data Management Guidance – Sampling and Sample Management. This document will be presented as part of the group’s one-day conference track, which will also cover a lot of other topics currently being addressed by the AQCG.

Target Audience

This conference track is intended for laboratory managers, supervisors and analysts, quality control managers, heads of quality control, qualified persons (QPs), analytical scientists, and senior laboratory staff. It is also relevant for professionals from quality assurance and contract laboratories, as well as representatives of regulatory authorities.

Congress Registration

Moderation

Dr Christopher Burgess

Programme

KEYNOTE: Artificial Intelligence in Pharmaceutical Industries
Dr Marcel Franke, Senior Scientist Predictive Formulation, Process Solutions/Upstream & Process Materials R&D Merck Life Science

Introduction to the Track and AQCG
Dr Christopher Burgess, Chairman ECA AQCG

The new AQCG Guideline on Sampling and Sample Management
Dr Christopher Burgess, Chairman ECA AQCG

  • Introduction & structure of the Guidance
  • Regulatory Requirements
  • Sampling and Testing Processes
  • Training
  • Sample Management & Traceability

Overview Instruments and Systems Lifecycle ‘Fitness for Intended Use’
Dr Bob McDowall, R.D. McDowall Limited

  • Revision of USP <1058>: Analytical Instrument and System Qualification
  • Main changes proposed to USP <1058>
  • 4Qs versus the updated lifecycle
  • The Good, The Bad and The Ugly of the USP <1058> update

Analytical Procedure Development Lifecycle ‘Fitness for Intended Purpose’
Patrick Jackson, GSK

  • ICH Q14
  • Analytical Target Profile – Define what constitutes “Fitness”
  • Method validation – Demonstrate method capability
  • Method verification – Demonstrate continued method performance (via robustness/ruggedness/system suitability charting)

Performance Qualification of Analytical Procedures ICH Q2 (R2) & the revision of USP <1225>
Dr Gerd Jilge, Member of the AQCG Board

  • Major changes of ICH Q2(R2) in comparison to ICH Q2(R1)
  • Revision of the USP <1225> “Validation of Compendial Procedures”
  • Comparison of ICH Q2(R2) and the revised USP <1225>
  • Updated ICH Q2(R2) and the revision of USP <1225>: Impact with respect to the Analytical Procedure Lifecycle Concept

Performance Qualification of Bioanalytical Procedures; Similarities and Differences
Margarita Sabater, Genentech

  • Key aspects of USP <1030> and the biological assays triage
  • Navigating between two guidance documents: ICH Q2(R2) and USP <1033>
  • Application of ATP to performance qualification acceptance criteria

AQbD and Its Impact on the Analytical Procedure Lifecycle
Dr Amanda Guiraldelli Mahr, RDC Group

  • Understanding the role of Analytical Quality by Design (AQbD) within the Analytical Procedure Lifecycle (APLC) framework
  • Applying risk assessment tools to guide method development and enhance robustness (Stage 1 of the APLC)
  • Presenting real-world case studies illustrating the development of LC-based analytical procedures using AQbD principles
  • Establishing effective analytical control strategies during method development to support lifecycle management

Ongoing Procedure Performance Verification (New USP Draft General Information Chapter <1221>)
Dr Joachim Ermer, Ermer Quality Consulting

  • 3 Stages of the Analytical Procedure Lifecycle (USP <1220>) & complementation of ICH Q2(R2) and Q14
  • Monitoring selected analytical procedure outputs to facilitate continual improvements: Prevention is better than cure
  • Performance metrics: Conformity, validity, quantitative performance parameters
  • Statistical Process Control (SPC) tools

Good Documentation Practices and Data Integrity (USP <1229>)
Dr Christopher Burgess, Chairman ECA AQCG

  • Original USP <1029> in 2018
  • Concepts & ideas for the revision
  • Contents of the revised version
  • Data governance and the next steps
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