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.