Trends in quality in the analytical laboratory. II. Analytical method validation and quality assurance

TrAC - Trends in Analytical Chemistry

Volumn 23, Issue 8, 2004, Pages 535-552

  Taverniers, Isabel ^a   De Loose, Marc ^a   Van Bockstaele, Erik ^a  

^a Centrum voor Landbouwkundig Onderzoek Gent CLO / Centre de Recherches Agronomiques Gand   (Belgium)

Author keywords

Accreditation; Analytical method validation; AOAC, Association of Official Analytical Chemists; AQA, Analytical quality assurance; ASTM, American Society for Testing and Material; Performance parameter; Quality assurance; Quality control

Indexed keywords

ACCREDITATION; COMPETITION; INFORMATION ANALYSIS; PERFORMANCE; STANDARDIZATION;

ANALYTICAL QUALITY ASSURANCE (AQA); INTERNAL QUALITY CONTROL (IQC); PROFICIENCY TESTING (PT); VALIDATIONS;

QUALITY ASSURANCE;

ACCREDITATION; ACCURACY; ANALYTIC METHOD; CALIBRATION; CLINICAL RESEARCH; EVALUATION; GOOD LABORATORY PRACTICE; INTERNATIONAL STANDARD UNIT; LABORATORY TEST; MEDICAL INFORMATION; MEDICAL RESEARCH; METHODOLOGY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; REVIEW; VALIDATION PROCESS;

EID: 4544342498     PISSN: 01659936     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.trac.2004.04.001     Document Type: Article

References (65)

1. Thompson M., Ellison S., Wood R. Pure Appl. Chem. 74:2002;835
2. CITAC/Eurachem Guide: Guide to Quality in Analytical Chemistry - An Aid to Accreditation, 2002 (http://www.Eurachem.bam.de).
3. Mesley R.J., Pocklington W.D., Walker R.F. Analyst (Cambridge, UK). 116:1991;975
4. Eurachem Guide: The fitness for purpose of analytical methods. A laboratory guide to method validation and related topics, LGC, Teddington, Middlesex, UK, 1998 (http://www.Eurachem.bam.de)
5. Thompson M., Wood R. Pure Appl. Chem. 67:1995;649
6. Fleming J., Albus H., Neidhart B., Wegschieder W. Accred. Qual. Assur. 1:1996;87
7. ICH-Q2A, Guideline for Industry: Text on Validation of Analytical Procedures, 1995 (http://www.fda.gov/cder/guidance/index.htm)
8. Huber L. Validation and Qualification in Analytical Laboratories. 1998;Interpharm Press, East Englewood, CO, USA
9. Wells R.J. Accred. Qual. Assur. 3:1998;189
10. Green M. Anal. Chem. 68:1996;305A
11. Eurachem Guide: Selection, use and interpretation of PT schemes by laboratories, 2000 (http://www.Eurachem.bam.de)
12. Eurachem/Eurolab/EA Guide EA-03/04: Use of proficiency testing as a tool for accreditation in testing, August 2001 - rev.01, 18pp
13. CEN, European Committee for Normalisation, 2004 (http://www.cenorm.be/ cenorm/index.htm)
14. AOAC International, Method Validation Programs (OMA/PVM Department), including Appendix D: Guidelines for collaborative study procedures to validate characteristics of a method of analysis, 2000 (http://www.aoac.org/vmeth/ devmethno.htm).
15. Horwitz W. Pure Appl. Chem. 67:1995;331
16. Thompson M., Wood R. Pure Appl. Chem. 65:1993;2123. (Also published in J. AOAC Int. 76 (1993) 926)
17. Currie L.A. Pure Appl. Chem. 67:1995;1699
18. Currie L.A., Svehla G. Pure Appl. Chem. 66:1994;595
19. Pocklington W.D. Pure Appl. Chem. 62:1990;149
20. ISO Guide 5725, 'Accuracy (trueness and precision) of measurement methods and results', ISO, Geneva, Switzerland, 1994
21. ISO Guide 43, 'Development and operation of laboratory proficiency testing', ISO, Geneva, Switzerland, 1984
22. ISO Guide 25, 'General requirements for the competence of calibration and testing laboratories', ISO, Geneva, Switzerland, 1990
23. ISO/IEC 17025, 'General requirements for the competence of calibration and testing laboratories', ISO, Geneva, Switzerland, 1999
24. ICH-Q2B, Guidance for Industry: Validation of Analytical Procedures: Methodology, 1996 (http://www.fda.gov/cder/guidance/index.htm)
25. ICH-Q6B, Harmonised Tripartite Guideline: Specifications: Test procedures and acceptance criteria for biotechnological/biological products, 1996 (http://www.fda.gov/cder/guidance/index.htm)
26. FDA/CDER/CVM, Guidance for Industry - Bioanalytical Method Validation, 2001, 22pp (http://www.fda.gov/cder/guidance/index.htm).
27. CX/MAS 01/4, Codex Alimentarius Commission, Codex Committee on Methods of Analysis and Sampling, Criteria for evaluating acceptable methods of analysis for Codex purposes, Agenda Item 4a of the 23rd Session, Budapest, Hungary, 26 February-2 March, 2001
28. CX/MAS 02/4, Codex Alimentarius Commission, Codex Committee on Methods of Analysis and Sampling (FAO/WHO), Proposed draft guidelines for evaluating acceptable methods of analysis, Agenda Item 4a of the 24th Session, Budapest, Hungary, 18-22 November 2002 + CX/MAS 02/4-Add.2 Dispute situations
29. CX/MAS 02/5, Codex Alimentarius Commission, Codex Committee on Methods of Analysis and Sampling (FAO/WHO), Criteria for evaluating acceptable methods of analysis for Codex purposes, Agenda Item 4b on the 24th Session, Budapest, Hungary, 18-22 November 2002 + CX/MAS 02/5-Add.1 Proposed amendment - Government comments
30. CX/MAS 02/11, Codex Alimentarius Commission, 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
31. CX/MAS 02/12, Codex Alimentarius Commission, 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
32. ILAC-G13: Guidelines for the requirements for the competence of providers of proficiency testing schemes, ILAC Technical Accreditation Issues Committee, 2000, 23pp (http://www.ilac.org/)
33. ILAC-G15: Guidance for accreditation to ISO/IEC 17025, ILAC Technical Accreditation Issues Committee, 2001, 16pp (http://www.ilac.org/)
34. ILAC-G18: The scope of accreditation and consideration of methods and criteria for the assessment of the scope in testing, ILAC Technical Accreditation Issues Committee, 2002, (http://www.ilac.org/www)
35. European Commission, Commission Decision 2002/657/EC implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results, Off. J. Eur. Commun. L 221/8, 17.8.2002
36. Holst-Jensen A., Berdal K.G. J. AOAC Int. 87:2004;1-9
37. Wood R. Trends Anal. Chem. 18:1999;624
38. Waters Corporation. Validation Guidelines: Terminology and Definitions (http://www.waters.com/WatersDivision/)
39. Hibbert D.B. Accred. Qual. Assur. 4:1999;352
40. Fleming J., Neidhart B., Albus H., Wegscheider W. Accred. Qual. Assur. 1:1996;135
41. Krull I.S., Swartz M. Anal. Lett. 32:1999;1067
42. Quevauviller Ph. Trends Anal. Chem. 23:2004;171
43. Segura M., Camara C., Madrid Y., Rebollo C., Azcarate J., Kramer G.N., Gawlik B.M., Lamberty A., Quevauviller Ph. Trends Anal. Chem. 23:2004;194
44. Holcombe G., Lawn R., Sargent M. Accred. Qual. Assur. 9:2004;198
45. Lauwaars M., Anklam E. Accred. Qual. Assur. 9:2004;253
46. Fleming J., Albus H., Neidhart B., Wegschieder W. Accred. Qual. Assur. 1:1996;191
47. Thompson M., Ellison S.L.R., Fajgelj A., Willets P., Wood R. Pure Appl. Chem. 71:1999;337
48. Vessman J. J. Pharmac. Biomed. Anal. 14:1996;867
49. Analytical Methods Committee, Analyst (Cambridge, UK) 112 (1987) 199
50. Fleming J., Albus H., Neidhart B., Wegschieder W. Accred. Qual. Assur. 2:1997;51
51. Huber W. Accred. Qual. Assur. 8:2003;213
52. Kuselman I., Sherman F. Accred. Qual. Assur. 4:1999;124
53. European Commission, Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/258/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC, Off. J. Eur. Commun. L 125 0010-0032, 23.05.1996
54. European Commission, Commission Decision 2003/181/EC amending Decision 2002/657/EC as regards the setting of minimum required performance limits (MRPLs) for certain residues in food of animal origin, Off. J. Eur. Commun. L 71/17 0017-0018, 15.3.2003
55. Antignac J.P., Le Bizec B., Monteau F., Andre F. Anal. Chim. Acta. 483:2003;325
56. K. De Wasch, H.F. De Brabander, D. Courtheyn, N. Van Hoof, S. Poelmans, H. Noppe, in: Proc. Euro Food Chem. XII: Strategies on Safe Food, vol. 1, Bruges, Belgium, 24-26 September, 2003, p. 45
57. von Holst C., Müller A., Björklund E., Anklam E. Eur. Food Res. Technol. 213:2001;154
58. Prichard E., Albus H., Neidhart B., Wegscheider W. Accred. Qual. Assur. 2:1997;348
59. Battaglia R. Accred. Qual. Assur. 1:1996;256
60. van der Voet H., van Rhijn J.A., van de Wiel H.J. Anal. Chim. Acta. 391:1999;159
61. Horwitz W., Albert R. J. AOAC Intern. 79:1996;589
62. Thompson M., Lowthian P.J. Analyst (Cambridge, UK). 118:1993;1495
63. King B., Boley N., Kannan G. Accred. Qual. Assur. 4:1999;280
64. EN45001, General criteria for the operation of testing laboratories, CEN/CENELEC, The Joint European Standard Institution, Brussels, Belgium, 1989
65. Pritzkow J. Accred. Qual. Assur. 8:2003;25