Conference: Analytical Instrument Qualification and System Validation

Objectives

During this conference track, participants will get an overview of the regulatory requirements for the qualification of analytical equipment and the software validation of computerized systems. Additionally, practical advice on successful approaches to calibration, qualification, validation, and routine monitoring of instrumentation and systems will be provided. Key requirements of the USP General Chapter <1058> will be presented. Furthermore, selected aspects and comments received related to the new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation will be highlighted and discussed.

Background

Analytical Instrument Qualification (AIQ) and software validation are processes to ensure that analytical instruments or equipment are suitable for their intended use and produce reliable and accurate results. AIQ is critical for ensuring the quality and integrity of analytical data generated by the instrument, which is essential for making informed decisions in research, development, and quality control processes. It helps minimize the risk of errors, ensure compliance with regulatory requirements, and maintain confidence in the accuracy and reliability of analytical results. Requirements and guidance for the pharmaceutical industry are laid down, among others, by the

• EU GMP Guide
• EU GMP Annex 15: Qualification and Validation
• EU GMP Annex 11: Computerised Systems
• US GMP 21 CFR 211
• USP <1058> Analytical Instrument Qualification
• GAMP 5 Guide

Currently, a USP Expert Committee is reviewing and revising USP <1058>, and the proposal is to change the title of the general chapter to Analytical Instrument Qualification and System Validation (AIQSV).

The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. 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. Comments and recommendations related to version 1 of the document can be submitted until 30 June 2024, by using a form linked in the AQCG member area.

Target Audience

This conference will be of significant value to

• Laboratory managers, supervisors and analysts
• Quality control managers
• Heads of quality control
• Qualified Persons (QPs)
• Analytical scientists
• Senior laboratory staff
• Responsible authorities

Registration

 

Programme

Key Note on 26 November: The Promise and Challenges of In Vitro and In Silico Models in Drug Development
Dr Julia Schüler, Charles River Laboratories
The presentation will highlight important developments in the drug development technology landscape influenced by the concept of 3R and the evolving legal landscape. General characteristics of the different applications, their translational relevance as well as adoption drivers will be discussed. Case studies from oncology drug development will help to elucidate these trends and their impact on future processes.

Key Note on 27 November: Trends & Challenges for the Development & Testing of Biotech Drug Products
Prof. Dr. Hanns-Christian Mahler, Chief Enablement Officer (CEO), ten23 health

Data Quality & Data Integrity Lifecycle Overview
Dr Christopher Burgess, Chairman ECA AQCG

Overview of the ECA AQCG Guide to AIQ&SV
Dr Bob McDowall, R.D. McDowall Limited

Risk Assessment in AIQ&SV
Dr Christopher Burgess, Chairman ECA AQCG

Application of the AIQSV Approach to a Bioassay Analytical Instrument and Software
Margarita Sabater, Genmab

Risk-Based Qualification of HPLC Systems
Martina Gjorgjevska, Bionika Pharmaceuticals

Eurachem Guide for The Fitness for Purpose of Analytical Equipment
Dr Ernst Halder, Eurachem

Ongoing Monitoring in Analytical Instrument Performance Qualification
Dr Joachim Ermer, Ermer Quality Consulting

Overview of General Chapter <1220> Analytical Procedure Lifecycle
Dr Christopher Burgess, Chairman ECA AQCG

Using the Analytical Target Profile (ATP) for Efficient Procedure Lifecycle Management and Enhanced Analytical Platform Adoption
Dr Amanda Guiraldelli Mahr, formerly USP

Importance of Change Control and Deviation Management over the Lifecycle
Silviya Dimitrova, TEVA Pharmaceuticals Industries

Efficient Analytical Instrument Qualification - Bridging Laboratory Needs and GMP Compliance
Dr Nadine Mendl, ten23 health

Lifecycle Roles and Responsibilities
Patrick Jackson, GSK

Comparison of ICH Q2(R2), ICH Q14 & USP <1220> with the Draft General Chapter in the Chinese Pharmacopeia
Dr Gerd Jilge, Board Member ECA AQCG

Consideration of Uncertainty in Evaluation of Accuracy and Precision according to the New ICH Q2(R2)
Dr Joachim Ermer, Ermer Quality Consulting