Guide on Analytical Instrument Qualification and System Validation (AIQSV)

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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.

  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
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