Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation
Monday, 29 April 2024 10.00 - 16.00 h
Course No. 21679
Speakers
Dr. Christopher Burgess
Burgess Analytical Consultancy
Dr. Bob McDowall
R.D. McDowall Ltd.
Dr Amanda Guiraldelli-Mahr
Scientific Affairs Manager at United States Pharmacopoeia
All times mentioned are CEST.
Objectives
The objectives of this Live Online Training are:
Understand the rationale for the lifecycle approach for new ECA AIQSV Guide
Learn the risk-based risk assessment approach to determine ‘fitness for use’
Overview of these principles to specific examples for analytical instruments and Systems
Provide an insight into the ECA AQCG collaboration with the USP
Background
Although qualification of analytical instruments has been a regulatory requirement in the GMP regulations since the 1970s, it was only the publication of United Stated Pharmacopoeia (USP) General Chapter <1058> on Analytical Instrument Qualification in 2008 that provided a formal requirement. This is still the only pharmacopoeial general chapter on the subject. In 2017, <1058> was updated and currently there are Stimuli to the Revision Process articles about moving from the 4Qs Model to a three phase lifecycle model to be congruent with USP <1220> on Analytical Procedure Lifecycle.
The ECA Analytical Quality Control Group (AQCG) Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV) was written to be a practical guide for risk-based instrument qualification and system validation. It adopts a three-phase lifecycle and not the 4Qs model similar to proposals for update of USP <1058>. The Guide has six appendices outlining how to qualify and validate common instruments and systems used in GMP regulated laboratories.
All participants receive a free copy of the new Guide and the other guides developed by the AQCG for download.
Target Group
This Live Online Training is aimed at the following:
Managers and staff from Quality Control and Analytical Development Laboratories of pharmaceutical companies, Contract Research Organisations and Contract Manufacturing Organisations involved in Qualifying analytical instruments and Systems
CSV staff involved in validating laboratory computerised Systems
Quality Assurance staff involved in reviewing laboratory qualification and validation documents
Auditors (internal and external) responsible for auditing qualification and validation of analytical Instruments and systems
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Seminar Programme as PDF