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.

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.

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

TAKEAWAY:

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.

If you would like to receive notifications about regulatory guidance, email: info@fwqrc.com