Metot validasyonu ile ilgili en temel kaynaklardan biri

EUROCHEM Guide- The Fitness for Purpose of Analytical Methods-
A Laboratory Guide to Method Validation and Related topics

Index
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