Validation and qualification: The fitness for purpose of mass spectrometry-based analytical methods and analytical systems

Analytical and Bioanalytical Chemistry

Volumn 386, Issue 1, 2006, Pages 38-45

  Careri, Maria ^a   Mangia, Alessandro ^a  

^a UNIVERSITY OF PARMA   (Italy)

Author keywords

Analytical methods; Analytical systems; Mass spectrometry; Qualification; Validation

Indexed keywords

MASS SPECTROMETRY; MATRIX ALGEBRA; MEASUREMENT THEORY; PROBLEM SOLVING; SENSITIVITY ANALYSIS;

ANALYTICAL METHODS; ANALYTICAL SYSTEMS; QUALIFICATION; VALIDATION;

LIQUID CHROMATOGRAPHY;

EID: 33747598684     PISSN: 16182642     EISSN: 16182650     Source Type: Journal    
DOI: 10.1007/s00216-006-0581-4     Document Type: Conference Paper

References (54)

1. ISO/IEC/EN 17025 (1999) General Requirements for the Competence of Calibration and Testing Laboratories, ISO, Geneva
2. Chan C, Lam H, Lee YC, Zhang XM (2004) (eds) Analytical method validation and instrument performance verification. Wiley, New York
3. The Fitness for Purpose of Analytical Methods (1998) A laboratory guide to method validation and related topics, Eurachem Guide, 1st English edn. 1.0, LGC (Teddington) Ltd. http://www.eurachem.ul.pt
4. Thompson M, Ellison SLR, Wood R (2002) Pure Appl Chem 74:835-855
5. ILAC C3, WG6 (1998) Guide to the validation of test method, draft, ILAC, Rhodes, Australia
6. ISO 5725, (1994) Accuracy (trueness and precision) of measurement methods and results, parts 1-4 and 6, International Organization for Standardization, Geneva
7. AOAC International (1995) Quick and Easy! AOAC Official Methods Programme, Gaithersburg, MD
8. CX/MAS 02/11, Codex Alimentarius Commission (2002) Codex Committee on Methods of Analysis and Sampling (FAO/WHO), Requirements for single-laboratory validation for Codex purposes. Agenda Item 8b of the 24th Session, Budapest, Hungary, 18-22 November 2002
9. CX/MAS 02/12, Codex Alimentarius Commission, (2002) Codex Committee on Methods of Analysis and Sampling (FAO/WHO), Validation of methods through the use of results from proficiency testing schemes, Agenda Item 8c on the 24th Session, Budapest, Hungary, 18-22 November 2002
10. Taverniers I, De Loose M, Van Bockstaele E (2004) Trends Anal Chem 23:535-552
11. Riediker S, Obrist H, Varga N, Stadler RH (2002) J Chromatogr A 966:15-23
12. Careri M, Elviri L, Mangia A, Zagnoni I (2002) Rapid Commun Mass Spectrom 16: 1821-1826
13. Mol HGJ, Van Dam RCJ, Steijger OM (2003) J Chromatogr A 1015:119-127
14. Ito Y, Goto T, Oka H, Matsumoto H, Takeba K (2004) J Chromatogr A 1042:107-111
15. Calbiani F, Careri M, Elviri L, Mangia A, Zagnoni I (2004) J AOAC Int 87:107-115
16. Fernández-Alba AR (2005) (ed) Chromatographic mass spectrometric food analysis for trace determination of pesticide residues, Elsevier, Amsterdam
17. Calbiani F, Careri M, Elviri L, Mangia A, Pistarà L, Zagnoni I (2004) J Chromatogr A 1042:123-130
18. Ferrer I, Heine CE, Thurman EM (2004) Anal Chem 76:1437-1444
19. Calbiani F, Careri M, Elviri L, Mangia A, Zagnoni I (2004) J Chromatogr A 1058:127-135
20. Barceló-Barrachina E, Moyano E, Galceran MT (2004) J Chromatogr A 1054:409-418
21. Ferrer I, García-Reyes JF, Fernández-Alba A (2005) Trends Anal Chem 24:671-682
22. Ferrer I, Thurman EM (2003) (eds) Liquid chromatography mass spectrometry/mass spectrometry, MS/MS and time-of-flight MS: analysis of emerging contaminants. American Chemical Society Symposium Series 850, American Chemical Society, Washington, DC
23. Čajka T, Hajšlová J (2004) J Chromatogr A 1058:251-261
24. Gibbons RD, Henion JD, Kaiser MA, Lewis DL, Matusik JE, Sphon JA, Stephany RW, Trubey RK (1997) Report on 1996 ASMS Fall workshop: limits to confirmation, quantitation, and detection. J Am Soc Mass Spectrom 8:1180-1190
25. Bethem RA, Boyd RK (1998) J Am Soc Mass Spectrom 9:643-648
26. Bethem R, Boison J, Gale J, Heller D, Lehotay S, Loo J, Musser S, Price P, Stein S (2003) J Am Soc Mass Spectrom 14:528-541
27. Thompson M, Ramsey MH (1995) Analyst 120:261-270
28. Sphon JA (1978) J Assoc Off Anal Chem 61:1247-1252
29. Li LYT, Campbell DA, Bennett PK, Henion J (1996) Anal Chem 68:3397-3404
30. EC Decision (2002) EC Decision 2002/657 Off J Eur Commun L221/8
31. Council Directive (1996) Council Directive 96/23/EC of 23 May 1996, Off J Eur Commun L125:10
32. André F, De Wasch KKG, De Brabander HF, Impens SR, Stolker LAM, van Ginkel L, Stephany RW, Schilt R, Courtheyn D, Bonnaire Y, Fürst P, Gowik P, Kennedy G, Kühn T, Moretain J-P, Sauer M (2001) Trends Anal Chem 20:435-445
33. Antignac J-P, Le Bizec B, Monteau F, André F (2003) Anal Chim Acta 483:325-334
34. Reemtsma T (2003) J Chromatogr A 1000:477-501
35. Mallet CR, Lu Z, Mazzeo JR (2004) Rapid Commun Mass Spectrom 18:49-58
36. Kebarle P (2000) J Mass Spectrom 35:804-817
37. King R, Bonfiglio R, Fernandez-Metzler C, Miller-Stein C, Olah T (2000) J Am Soc Mass Spectrom 11:942-950
38. van Hout MWJ, Niederlander HAG, de Zeeuw RA, de Jong GJ (2003) Rapid Commun Mass Spectrom 17:245-250
39. Bonfiglio R, King R, Olah T, Merkle K (1999) Rapid Commun Mass Spectrom 13:1175-1185
40. Avery M (2003) Rapid Commun Mass Spectrom 17:197-201
41. Dams R, Huestis M, Lambert W, Murphy C (2003) J Am Soc Mass Spectrom 14:1290-1294
42. Souverain S, Rudaz S, Veuthey J-L (2004) J Chromatogr A 1058:61-66
43. Alder L, Lüderitz S, Lindtner K, Stan H-J (2004) J Chromatogr A 1058:67-79
44. Kloepfer A, Quintana JB, Reemtsma T (2005) J Chromatogr A 1067:153-160
45. Chin C, Zhang ZP, Karnes HT (2004) J Pharm Biomed Anal 35:1149-1167
46. Benijts T, Dams R, Lambert W, De Leenheer A (2004) J Chromatogr A 1029:153-159
47. Matuszewski BK, Constanzer ML, Chavez-Eng CM (2003) Anal Chem 75:3019-3030
48. Matuszewski BK (2006) J Chromatogr B 830:293-300
49. Stüber M, Reemtsma T (2004) Anal Bioanal Chem 378:910-916
50. Rogatsky E, Stein D (2005) J Am Soc Mass Spectrom 16:1757-1759
51. Taylor PJ (2005) Clin Biochem 38:328-334
52. Guidance for industry. Bioanalytical method validation. http://www.fda.gov/cder/guidance/guidance.htm, May 2001
53. Equipment Validation and Qualification. http://www.labcompliance.com/ equipment/faq.htm
54. American Society of Mass Spectrometry (1997) Guidelines for writing an SOP for mass spectrometry prepared by the Measurements and Standards Committee of the American Society for Mass Spectrometry, Santa Fe, NM