The Eurachem reading list

12. Equipment qualification

Standards

ASTM E275 Standard Practice for Describing and Measuring Performance of Ultraviolet and Visible Spectrophotometers, DOI: 10.1520/E0275-08R22 (astm.org)
ASTM E1866 Guide for establishing Spectrophotometer Performance Tests, DOI: 10.1520/E1866-97R21 (astm.org)
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

Leaflets

Eurachem information leaflets (eurachem.org)
- Fitness for the intended use of analytical equipment and systems (2025)

Articles and reports

K. Fritsch, EURAMET cg-18 – state-of-the-art calibration guideline for non-automatic weighing instruments, Acta IMEKO, vol. 8, no. 3, article 3, September 2019, https://doi.org/10.21014/acta_imeko.v8i3.655
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
P. J. Potts, Evaluation of analytical instrumentation. Part XXVII: a guide to good practice in the purchase of analytical instrumentation, Anal. Methods, 2018, 10, 3303 https://doi.org/10.1039/c8ay90075b
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

Websites and web resources

Management of Equipment in an ISO/IEC 17025:2017 Accredited Laboratory, Part 1: Classifications of Laboratory Equipment, https://articles.davidtrew.co.uk/classifications_of_laboratory_equipment1.html
Management of Equipment in an ISO/IEC 17025:2017 Accredited Laboratory, Part 2: Equipment Lifecycle Models, https://articles.davidtrew.co.uk/equipment_lifecycle_models1.html