The new ECA Guide on 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. 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).

In chapter 1 of the document, the authors write: "This ECA Guide describes and discusses the lifecycle processes for specifying, purchasing, commissioning, calibrating or verifying correct operation against instrument specifications. Configuring application and control software and ensuring continued operation of analytical instruments and systems as well as decommissioning / retirement of an instrument or system. The primary focus of this guide is for analytical instruments and systems controlling them that are operated under the pharmaceutical GMP regulations. [...] This Guide is intended to provide a synopsis and discussion of current regulatory guidelines and best practices in order that a laboratory user may decide on the scientifically sound and appropriate qualification approach to ensure that analytical instruments and systems are ‘fit for intended use’ consistent with their particular Quality Management System (QMS) and compliance requirements."

Contents

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

The Guide is divided into the following main chapters:

• 1. Rationale and Purpose of this Guide
• 2. Key Regulations, Standards and Guidance Documents
• 3. Brief History of AIQ and AIQSV
• 4. Roles and Responsibilities in AIQSV
• 5. Role of AIQSV in Ensuring Data Integrity
• 6. Analytical Instrument Qualification and System Lifecycle Process Flow
• 7. Risk-Based Classification of Analytical Instruments and Systems
• 8. System Risk Assessment
• 9. Why Do We Need an AIQSV Lifecycle?
• 10. Lifecycle Stage 1: Specification and Selection
• 11. Lifecycle Stage 2: Qualification/Validation of Instruments and Systems
• 12. Lifecycle Stage 3: Continued Performance Verification
• 13. How To Appendices
• 14. Appendix 1: Group A; Apparatus
• 15. Appendix 2: Group B Instruments
• 16. Appendix 3: Analytical Balance Grouping is Dependent on Intended Use
• 17. Appendix 4: Group C Systems
• 18. Appendix 5: Chromatography From Group B Instrument to Group C Networked System
• 19. Appendix 6: Group C3 NIR spectrometer for identification of raw materials using macros
• 20. Technical Glossary
• 21. References

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.

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.

Documents of the ECA Analytical Quality Control Group

The Analytical QC Group has already developed or contributed to the following guides, which are also available to members free of charge:

• SOP on Out-of-Specification (OOS) Results  
• Guidance: Out of Expectation (OOE) and Out of Trend (OOT) Results
• Guidance: GMP Data Governance and Data Integrity