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The Fitness for Purpose of Analytical Methods
EURACHEM Guide
The Fitness for Purpose of
Analytical Methods
A Laboratory Guide to Method Validation
and Related Topics
This document has been developed by a EURACHEM Working Group from a draft originally produced
by LGC. The membership of the EURACHEM group is
Prof P de Bievre
IRMM, Belgium
Dr D Böttger
Hoechst AG, Germany
Dr C Eastwood
Zeneca Specialties, UK
Prof J Hlavay
University of Veszprem, Hungary
Mr M Holmgren
SP, Sweden (Eurolab Secretariat)
Dr W Horwitz
Food and Drug Administration, USA
Dr M Lauwaars
AOAC International, The Netherlands
Dr B Lundgren
SP, Sweden
Prof L Massart
Vrije Universiteit Brussel, Belgium
Prof J Miller
University of Loughborough, UK
Dr J Morkowski
EMPA, Switzerland
Dr B te Nijenhuis
Working Party on Analytical Chemistry (Secretary), The Netherlands
Ms B Nyeland
National Environment Research Institute, Denmark
Dr R Philipp
BAM, Germany
Dr P Radvila
EMPA St Gallen, Switzerland
Prof J Smeyers-Verbeke
Vrije Universiteit Brussel, Belgium
Dr R Stephany
RIVM, The Netherlands
Dr M Suchanek
Prague Institute of Chemical Technology, Czech Republic
Ms C Vandervoorst
Dr L Willems Instituut vzv, Belgium
Dr H Verplaetse
Ministry of Economic Affairs - Central Laboratory, Belgium
Ms H Wallien
VTT, Finland
Dr M Walsh
The State Laboratory, Ireland
Prof W Wegscheider
Leoben University of Mining & Metallurgy, Austria
Dr D Westwood
Environment Agency, UK
Mr H J van de Wiel
RIVM, The Netherlands
i
First Internet Version, December 1998
First English Edition 1.0 - 1998
The Fitness for Purpose of Analytical Methods
EURACHEM Guide
The Fitness for Purpose of
Analytical Methods
A Laboratory Guide to Method Validation
and Related Topics
This document has been developed by a EURACHEM Working Group from a draft originally produced
by LGC. The membership of the EURACHEM group is listed in Annex C.
The UK input to this Guide and publication of this edition was in part supported under contract with the
UK Department of Trade and Industry as part of the National Measurement System Valid Analytical
Measurement (VAM) Programme.
Comments are invited on this document and should be sent to:
Mr David Holcombe
Drafting Secretary for EURACHEM Working Group
LGC, Queens Rd, Teddington, Middlesex, TW11 0LY, United Kingdom
(
: Int + 44 181 943 7613,
4
: Int + 44 181 943 2767,
:+
: dgh@lgc.co.uk
English Edition 1.0 - 1998
ISBN: 0-948926-12-0
Ruling language
The text may be freely translated into other languages, but where such action results in a dispute over
interpretation, the guidance given in this English version is taken as being the definitive version.
Copyright of text
Copyright of the guidance presented in this guide is the property of the organisations represented by the
working group members as listed in Annex C. All rights are reserved. This guidance may be
downloaded for personal and non-commercial use, but no part of the guide may be distributed, published
or stored in any retrieval system, in any media, by persons other than EURACHEM members, without
the written consent of the EURACHEM Secretariats. Similarly, enquiries regarding the translation,
i
production and distribution of new editions of this guide should be directed to the EURACHEM
Secretariats
This edition is Copyright
ª
LGC (Teddington) Ltd, 1998
Contents
1.
Preface
1
2.
Introduction
2
3.
What is method validation?
3
4.
Why is method validation necessary?
3
(a)
Importance of analytical measurement
3
(b)
The professional duty of the analytical chemist
4
5.
When should methods be validated?
5
6.
How should methods be validated?
5
(a)
Who carries out method validation?
5
(b)
Deciding what degree of validation is required
7
(c)
The analytical requirement
7
(d)
Method development
10
(e)
The different performance parameters of a method and what
they show
10
(f)
The tools of validation
24
7.
Using validated methods
26
8.
Using validation data to design QC
27
9.
Documentation of validated methods
30
10.
Implications of validation data for calculating results and
reporting
31
11.
References and bibliography
33
Annex A
Definitions
39
Annex B
Method documentation protocol
50
Annex C
EURACHEM Working Group
54
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