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The Fitness for Purpose of Analytical Methods : A Laboratory Guide to Method Validation and Related Topics

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Book Id: WPLBN0000660616
Format Type: PDF eBook
File Size: 235.29 KB.
Reproduction Date: 2006
Full Text

Title: The Fitness for Purpose of Analytical Methods : A Laboratory Guide to Method Validation and Related Topics  
Language: English
Subject: Literature & thought, Business literature, Business.
Collections: Business Reference
Publication Date:

Business Publication

Excerpt: A Laboratory Guide to Method Validation and Related Topics Preface: An initiative in the UK to promote good practice in analytical measurement has identified six principles of analytical practice which, taken together, are considered to constitute best practice. The six principles which are described in more detail in a separate guide are: 1. ?Analytical measurements should be made to satisfy an agreed requirement.? (i.e. to a defined objective) 2. ?Analytical measurements should be made using methods and equipment which have been tested to ensure they are fit for purpose.? 3. ?Staff making analytical measurements should be both qualified and competent to undertake the task.? (and demonstrate that they can perform the analysis properly). 4. ?There should be a regular independent assessment of the technical performance of a laboratory? 5. ?Analytical measurements made in one location should be consistent with those made elsewhere.? 6. ?Organizations making analytical measurements should have well defined quality control and quality assurance procedures? These principles are equally relevant to laboratories whether they are working in isolation or producing results which need to be compared with those from other laboratories.

Table of Contents
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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