Dr. Christopher Burgess
Burgess Analytical Consultancy
Referent:innen
Dr. Bob McDowall
R.D. McDowall Ltd.
All times mentioned are CEST.
Zielsetzung
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
Hintergrund
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.
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.
Zielgruppe
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
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical- information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Introduction to the Live Online Training and the AQCG
Dr Markus Funk (CONCEPT HEIDELBERG and Administration Manager of the ECA AQCG)
Dr Markus Funk (CONCEPT HEIDELBERG and Administration Manager of the ECA AQCG)
- Overview of the structure and activities of the ECA FOUNDATION
- Introduce the ECA AQCG Board
- AQCG Aims & Objectives
- ECA AQCG Published Guidelines
Introduction to the new AQCG ECA AIQSV Guide
Dr Chris Burgess, Burgess Analytical Consultancy Ltd, UK
Dr Chris Burgess, Burgess Analytical Consultancy Ltd, UK
- Rationale for the Guide and the development process
- Acknowledgements
- What’s in and what’s out of the AIQSV guide
- Collaborative 2-day meeting with USP on practical implementation at PharmaLab on 26/27 November 2024 in Düsseldorf/Neuss
An overview of the AIQSV Lifecycle
Dr Chris Burgess, Burgess Analytical Consultancy Ltd, UK
Dr Chris Burgess, Burgess Analytical Consultancy Ltd, UK
- Why the 4Qs model is inadequate for most analytical instruments and Systems
- IQ, OQ and PQ dropped by FDA in 2002 and GAMP in 2008
- Lifecycle phases and threads
- Phase 1: Specify and Select
- Phase 2: Qualification / Validation of Instruments and Systems
- Phase 3: Continued Performance Verification
- Who does what; Roles and Responsibilities
Evolution of Analytical Procedure Validation: The Analytical Procedure Lifecycle
Dr Amanda Guiraldelli-Mahr, United States Pharmacopoeia
Dr Amanda Guiraldelli-Mahr, United States Pharmacopoeia
- USP’s journey in the creation of compendial approaches incorporating QbD principles
- Introduction to the Analytical Procedure Lifecycle Framework described in USP <1220>
- USP Analytical Instrument Qualification (AIQ) Joint Subcommittees and collaborative efforts
- Stimuli Articles on AIQ, update on the revision of USP <1058> and collaborative 2-day Workshop to allow broader stakeholder input & debate
- Planned two-day AQCG/USP session at PharmaLab 2024
AIQSV Risk Assessment; an Integrated Approach
Dr Bob McDowall, R.D.McDowall Limited, UK
Dr Bob McDowall, R.D.McDowall Limited, UK
- Overview of the AIQSV Guide risk assessment
- Understanding why a different intended use defines a different USP <1058> Group and sub type for the same make and model of instrument/System
- Analytical computerised systems are not created equal: validation approaches vary from a single integrated validation document to a networked CDS
Overview of Qualification of Chromatographs and Validation of Chromatography Data Systems
Dr Bob McDowall, R.D.McDowall Limited, UK
Dr Bob McDowall, R.D.McDowall Limited, UK
- Laboratory specification of liquid chromatographs versus supplier specifications
- Supplier’s qualification protocols and qualification data
- Risk based validation of a chromatography data System
- Specifying testable or verifiable user requirements
- How to leverage the supplier software development and testing
- Practical user acceptance testing
Wash Up Session & Close of Meeting
Dr Chris Burgess, Burgess Analytical Consultancy Ltd, UK
Dr Chris Burgess, Burgess Analytical Consultancy Ltd, UK
- Review and feedback on Guide
- Soliciting topics for the two-day AIQSV Guide meeting at PharmaLab 2024
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