Conference: Analytical Instrument Qualification and System Validation

Background & Objectives

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).

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.

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.

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Conference Registration

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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 and responsible authorities.

Moderation

Dr Christopher Burgess

Tuesday, 26 November 2024

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.

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

• Data quality, Data Integrity & Data Governance; Is there a difference?
• Why the 4Qs model is inadequate for most analytical instruments and systems
• An integrated approach; Lifecycle phases and threads
• Who does what; Roles and Responsibilities

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

• Rationale for the Guide and the development process
• What’s in and what’s out of the AIQSV guide
• Importance of the technical appendices:
  • Practical “How To” Examples of Qualification and Validation
• Acknowledgements

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

• Criticality of the User Requirements Specification
• Analytical instruments & systems are not created equal: qualification/validation approaches depend on intended use
• Understanding why a different intended use could define a different USP <1058> Group and sub type for the same make and model of instrument
• Overview of the AIQSV Guide risk assessment process

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

• Preparation of risk assessment
• Considerations for different system categories
• URS and integrated qualification
• Plan for ongoing performance qualification

Risk-Based Qualification of HPLC Systems
Martina Gjorgjevska, THE FORCE CT

• Principles of Risk-Based Qualification for HPLC
• Risk Assessment for HPLC Systems
• Live Examples of Risk-Based HPLC Qualification
• Implementation Strategies (Step-by-step guide on integrating risk management into HPLC qualification: Decision making based on risk assessment outcomes)
• Benefits of a Risk-Based Approach
• Challenges and Mitigation
• Emerging trends in HPLC technologies and risk management

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

• Background and objectives
• Rationale for the Guide
• Overview of content

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

• Importance of continual performance monitoring within the analytical lifecycle
• Suitable instrument monitoring parameters
• Tools for ongoing monitoring (run & control charts)
• Reliable performance parameters (long-term averages)
• Crucial interface: Contributions from instrument suppliers