The new AQCG ECA AIQSV Guide: Download, Training, Comments

Recommendation

14-16 May 2024
Vienna, Austria

Analytical Instrument Qualification
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. It is intended to be a practical guide for risk-based instrument qualification and system validation. Version 1 of the new document was adopted at the ACQC Board Meeting in November 2023 in Düsseldorf/Neuss.

The document was written by Dr Christopher Burgess (Chairman of the AQCG Board) and Dr Bob McDowall (Members of the AQCG Board and of the ECA IT Compliance Interest Group).

The content can be summarized as follows:

• Guide not a Guideline
• 12 Chapters
• 6 illustrative ‘How To’ Appendices
• Technical Glossary (19 pages)
• 111 References
• 38 figures
• 24 tables
• 153 pages in total

Download

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. For further information and to apply for a free membership, please visit the group's website.

Live Online Training on 29 April 2024

The AQCG has organized a Live Online Training on Monday, 29 April 2024 from 10.00 to 16.00 h CEST. During the training, Dr Christopher Burgess and Dr Bob McDowall will provide an insight into the new Guide and the rationale for the lifecycle approach. The training includes a USP speaker update on the Analytical Procedure Lifecycle by Dr Amanda Guiraldelli-Mahr (Scientific Affairs Manager at USP).

The programme includes the following lectures:

• Introduction to the new AQCG ECA AIQSV Guide
• An overview of the AIQSV Lifecycle
• Evolution of Analytical Procedure Validation: The Analytical Procedure Lifecycle
• AIQSV Risk Assessment; an Integrated Approach
• Overview of Qualification of Chromatographs and Validation of Chromatography Data Systems

Comments

The ECA Analytical Quality Control Group (AQCG) is interested in your opinion on the new Guide. Comments and recommendations can be submitted until 30 June 2024 by using a form that is linked in the AQCG member area.

After this deadline, all comments will be reviewed and evaluated by the AQCG Board. It is further planned to discuss selected aspects at PharmaLab 2024, which will take place from 25-27 November 2024 in Düsseldorf/Neuss. It is then decided which comments will be taken into account when preparing version 2 of the Guide.