The Eurachem reading list

12. Equipment qualification

Standards

  • Qualification of Equipment – Core document PA/PH/OMCL (08) 73 R7, 2023. A total of eleven annexes deal with the qualification of specific device types (https://www.edqm.eu/ )
  • PIC/S Guide to Good Manufacturing Practice for medical products (higher-level document for the qualification of devices and the validation of processes in the pharmaceutical industry) – Annexes, PE 009-17 (Annex15), Geneva: PIC/S Secretariat, 2023
  • PIC/S Guide to Good Manufacturing Practice for medical products – Annexes, PE 009-17 (Annex 11, Computer validation requirements), Geneva: PIC/S Secretariat, 2023
  • EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 15: Qualification and Validation, 2015
  • EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 11: Computerised Systems, 2011
  • GAMP® (Good Automated Manufacturing Practice) (https://ispe.org/)
  • USP General Chapter <1058>, Analytical Instrument Qualification, https://doi.org/10.31003/USPNF_M1124_01_01

 Guides

  • Burgess, B. McDowall, Guide on Analytical Instrument and System Qualification – A Lifecycle Approach, 2023, European Compliance Academy, (https://www.gmp-compliance.org/)

Books

  • C. Chan, I.C. Lee, H. Lam, X. Zhang, Analytical Method Validation and Instrument Performance Verification, John Wiley & Sons Inc., Hoboken, New Jersey, USA, 2004

 Articles and reports

  • Bedson, M. Sargent, The development and application of guidance on equipment qualification of analytical instruments, Accred. Qual Assur., 1996, 1, 265–274, https://doi.org/10.1007/s007690050083
  • Burgess, and R. McDowall, Stimuli to the Revision Process: An Integrated and Harmonized Approach to Analytical Instrument Qualification and Computerized System Validation – A Proposal for an Extension of Analytical Instrument Qualification <1058>. Pharm. Forum, 2012, 38(1), 235-242
  • Burgess, J. Weitzel, J. Roussel, O. Quattrocchi, J. Ermer, R. Slabicky, G. P. Martin, and G. Vivó-Truyols, Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle. Pharm. Forum, 2022, 48(1)
  • M. Freeman, M. Leng, D. Morrison, R.P. Munden, Position paper on the qualification of analytical equipment, Pharm Tech Europe, 1995, 40-46