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

TrAC Trends in Analytical Chemistry - Tập 23 Số 8 - Trang 535-552 - 2004
Isabel Taverniers1, Marc De Loose1, Erik Van Bockstaele1
1Department for Plant Genetics and Breeding (DvP), Centre for Agricultural Research (CLO), Ministry of the Flemish Community, Caritasstraat 21, B-9090 Melle, Belgium

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Tài liệu tham khảo

Thompson, 2002, Pure Appl. Chem, 74, 835, 10.1351/pac200274050835

CITAC/Eurachem Guide: Guide to Quality in Analytical Chemistry – An Aid to Accreditation, 2002 (http://www.Eurachem.bam.de).

Mesley, 1991, Analyst (Cambridge, UK), 116, 975, 10.1039/an9911600975

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)

Thompson, 1995, Pure Appl. Chem, 67, 649, 10.1351/pac199567040649

Fleming, 1996, Accred. Qual. Assur, 1, 87, 10.1007/s007690050041

ICH-Q2A, Guideline for Industry: Text on Validation of Analytical Procedures, 1995 (http://www.fda.gov/cder/guidance/index.htm)

1998

Wells, 1998, Accred. Qual. Assur, 3, 189, 10.1007/s007690050220

Green, 1996, Anal. Chem, 68, 305A, 10.1021/ac961912f

Eurachem Guide: Selection, use and interpretation of PT schemes by laboratories, 2000 (http://www.Eurachem.bam.de)

Eurachem/Eurolab/EA Guide EA-03/04: Use of proficiency testing as a tool for accreditation in testing, August 2001 – rev.01, 18pp

CEN, European Committee for Normalisation, 2004 (http://www.cenorm.be/cenorm/index.htm)

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).

Horwitz, 1995, Pure Appl. Chem, 67, 331, 10.1351/pac199567020331

Thompson, 1993, Pure Appl. Chem, 65, 2123, 10.1351/pac199365092123

Currie, 1995, Pure Appl. Chem, 67, 1699, 10.1351/pac199567101699

Currie, 1994, Pure Appl. Chem, 66, 595, 10.1351/pac199466030595

Pocklington, 1990, Pure Appl. Chem, 62, 149, 10.1351/pac199062010149

ISO Guide 5725, `Accuracy (trueness and precision) of measurement methods and results', ISO, Geneva, Switzerland, 1994

ISO Guide 43, `Development and operation of laboratory proficiency testing', ISO, Geneva, Switzerland, 1984

ISO Guide 25, `General requirements for the competence of calibration and testing laboratories', ISO, Geneva, Switzerland, 1990

ISO/IEC 17025, `General requirements for the competence of calibration and testing laboratories', ISO, Geneva, Switzerland, 1999

ICH-Q2B, Guidance for Industry: Validation of Analytical Procedures: Methodology, 1996 (http://www.fda.gov/cder/guidance/index.htm)

ICH-Q6B, Harmonised Tripartite Guideline: Specifications: Test procedures and acceptance criteria for biotechnological/biological products, 1996 (http://www.fda.gov/cder/guidance/index.htm)

FDA/CDER/CVM, Guidance for Industry – Bioanalytical Method Validation, 2001, 22pp (http://www.fda.gov/cder/guidance/index.htm).

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

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

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

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

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

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/)

ILAC-G15: Guidance for accreditation to ISO/IEC 17025, ILAC Technical Accreditation Issues Committee, 2001, 16pp (http://www.ilac.org/)

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)

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

Holst-Jensen, 2004, J. AOAC Int, 87, 1, 10.1093/jaoac/87.4.927

Wood, 1999, Trends Anal. Chem, 18, 624, 10.1016/S0165-9936(99)00150-8

Waters Corporation. Validation Guidelines: Terminology and Definitions (http://www.waters.com/WatersDivision/)

Hibbert, 1999, Accred. Qual. Assur, 4, 352, 10.1007/s007690050381

Fleming, 1996, Accred. Qual. Assur, 1, 135, 10.1007/s007690050049

Krull, 1999, Anal. Lett, 32, 1067, 10.1080/00032719908542878

Quevauviller, 2004, Trends Anal. Chem, 23, 171, 10.1016/S0165-9936(04)00314-0

Segura, 2004, Trends Anal. Chem, 23, 194, 10.1016/S0165-9936(04)00502-3

Holcombe, 2004, Accred. Qual. Assur, 9, 198, 10.1007/s00769-003-0747-0

Lauwaars, 2004, Accred. Qual. Assur, 9, 253, 10.1007/s00769-004-0767-4

Fleming, 1996, Accred. Qual. Assur, 1, 191, 10.1007/s007690050063

Thompson, 1999, Pure Appl. Chem, 71, 337, 10.1351/pac199971020337

Vessman, 1996, J. Pharmac. Biomed. Anal, 14, 867, 10.1016/0731-7085(95)01679-1

Analytical Methods Committee, Analyst (Cambridge, UK) 112 (1987) 199

Fleming, 1997, Accred. Qual. Assur, 2, 51, 10.1007/s007690050097

Huber, 2003, Accred. Qual. Assur, 8, 213, 10.1007/s00769-003-0626-8

Kuselman, 1999, Accred. Qual. Assur, 4, 124, 10.1007/s007690050331

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

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

Antignac, 2003, Anal. Chim. Acta, 483, 325, 10.1016/S0003-2670(02)01379-X

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

von Holst, 2001, Eur. Food Res. Technol, 213, 154, 10.1007/s002170100326

Prichard, 1997, Accred. Qual. Assur, 2, 348, 10.1007/s007690050163

Battaglia, 1996, Accred. Qual. Assur, 1, 256, 10.1007/s007690050079

van der Voet, 1999, Anal. Chim. Acta, 391, 159, 10.1016/S0003-2670(99)00109-9

Horwitz, 1996, J . AOAC Intern, 79, 589, 10.1093/jaoac/79.3.589

Thompson, 1993, Analyst (Cambridge, UK), 118, 1495, 10.1039/an9931801495

King, 1999, Accred. Qual. Assur, 4, 280, 10.1007/s007690050369

EN45001, General criteria for the operation of testing laboratories, CEN/CENELEC, The Joint European Standard Institution, Brussels, Belgium, 1989

Pritzkow, 2003, Accred. Qual. Assur, 8, 25, 10.1007/s00769-002-0509-4