PharmaLab 2025: Brief Summary of AQCG Track - Save the Date for 2026!

PharmaLab 2025 took place from 24 to 26 November in Neuss, featuring a total of nine parallel conferences and two pre-conference workshops with more than 100 presentations.

Analytical Quality and Lifecycle Concepts

As part of PharmaLab 2025, the ECA Analytical Quality Control Group (AQCG) organised a dedicated one-day conference track entitled “Analytical Quality and Lifecycle Concepts”. Moderated by Dr Christopher Burgess (Chairman of the AQCG), the track focused on lifecycle-based approaches to analytical procedures, instruments and data, reflecting recent developments in ICH guidelines and USP chapters.

The track was opened by Dr Christopher Burgess with an “Introduction to the Track and AQCG”. He introduced the objectives of the Analytical Quality Control Group, its interactions with other ECA groups, and gave an overview of the available guidances developed by the AQCG.

In his subsequent talk, “The New AQCG Guideline on Sampling and Sample Management”, Dr Burgess highlighted sampling as one of the most critical and risk-sensitive steps in pharmaceutical analysis. He emphasised that representative sampling, traceability and controlled sample handling are essential prerequisites for reliable analytical results.

The focus then shifted to analytical instruments and systems with Dr Bob McDowall’s presentation “Overview of Instruments and Systems Lifecycle – ‘Fitness for Intended Use’”. He discussed the proposed revision of USP <1058> and critically reviewed the limitations of the traditional 4Qs model. Particular attention was given to lifecycle-based qualification concepts and their implications for change control and ongoing performance verification.

Patrick Jackson continued the programme with “Analytical Procedure Development Lifecycle – ‘Fitness for Intended Purpose’”. He demonstrated how structured method development, based on the Analytical Target Profile, risk assessment and Design of Experiments, supports robust analytical procedures and reduces lifecycle risks during routine use.

With “Performance Qualification of Analytical Procedures: ICH Q2(R2) and the Revision of USP <1225>”, Dr Gerd Jilge provided a comprehensive overview of the major changes introduced by ICH Q2(R2) and the revised draft of USP <1225>. He explained how both documents are closely linked to ICH Q14 and strengthen the lifecycle concept by harmonising performance characteristics and validation strategies.

Bioanalytical aspects were addressed by Margarita Sabater in her presentation “Performance Qualification of Bioanalytical Procedures – Similarities and Differences”. She highlighted the inherent variability of bioassays and explained how USP <1030> and related chapters can be applied in combination with ICH Q2(R2) to define scientifically justified acceptance criteria within an ATP-based framework.

In “AQbD and its Impact on the Analytical Procedure Lifecycle”, Dr Amanda Guiraldelli Mahr illustrated how Analytical Quality by Design principles can be integrated into analytical development. Using practical case studies, she showed how Design of Experiments and modelling tools improve method understanding, robustness and regulatory flexibility.

The lifecycle concept was further extended by Dr Joachim Ermer with his presentation “Ongoing Procedure Performance Verification (New USP Draft General Information Chapter <1221>)”. He introduced the new USP chapter <1221> and explained how continuous performance monitoring and trend analysis support reliable routine use and proactive risk management throughout the analytical lifecycle.

The track concluded with Dr Christopher Burgess’ presentation “Good Documentation Practices and Data Integrity (USP <1029>)”. He outlined the proposed revision of USP <1029> and its expanded focus on ALCOA++ principles, emphasising the role of documentation, traceability and data integrity as the foundation of lifecycle-based analytical quality systems.

PharmaLab 2026 – at a New Venue

The 14th PharmaLab will take place from 23 to 25 November 2026 at the Darmstadtium, the Congress Centre Darmstadt, near Frankfurt Airport.

The 13-year history of PharmaLab continues in the science city of Darmstadt at a modern conference centre with state-of-the-art and sustainable technical facilities. Three pre-conference workshops and eight parallel conference tracks are planned, along with many opportunities for networking and exchanging ideas with speakers, colleagues and exhibitors. The AQCG will again contribute with a pre-conference workshop as well as a dedicated one-day conference track.

Detailed information about the congress, its various conference topics and the accompanying exhibition will be published on the conference website in a few weeks.