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