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Harmonized Guidelines for Singlelaboratory Validation of Methods of Analysis

By Thompson, Michael

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Book Id: WPLBN0000659939
Format Type: PDF eBook
File Size: 225.41 KB.
Reproduction Date: 2006

Title: Harmonized Guidelines for Singlelaboratory Validation of Methods of Analysis  
Author: Thompson, Michael
Volume:
Language: English
Subject: Literature & thought, Business literature, Business.
Collections: Business Reference
Historic
Publication Date:
Publisher:

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Thompson, M. (n.d.). Harmonized Guidelines for Singlelaboratory Validation of Methods of Analysis. Retrieved from http://www.worldpubliclibrary.org/


Description
Business Publication

Excerpt
Excerpt: Reliable analytical methods are required for compliance with national and international regulations in all areas of analysis. It is accordingly internationally recognized that a laboratory must take appropriate measures to ensure that it is capable of providing and does provide data of the required quality. Such measures include: // using validated methods of analysis; // using internal quality control procedures; // participating in proficiency testing schemes; and // becoming accredited to an International Standard, normally ISO/IEC 17025. It should be noted that accreditation to ISO/IEC 17025 specifically addresses the establishment of traceability for measurements, as well as requiring a range of other technical and management requirements including all those in the list above.

Table of Contents
CONTENTS 1. INTRODUCTION 837 1.1 Background 1.2 Existing protocols, standards, and guides 2. DEFINITIONS AND TERMINOLOGY 839 2.1 General 2.2 Definitions used in this guide only 3. METHOD VALIDATION, UNCERTAINTY, AND QUALITY ASSURANCE 839 4. BASIC PRINCIPLES OF METHOD VALIDATION 839 4.1 Specification and scope of validation 4.2 Testing assumptions 4.3 Sources of error in analysis 4.4 Method and laboratory effects 5. CONDUCT OF VALIDATION STUDIES 843 6. EXTENT OF VALIDATION STUDIES 844 7. RECOMMENDATIONS 844 APPENDIX A: NOTES ON THE REQUIREMENTS FOR STUDY OF METHOD 845 PERFORMANCE CHARACTERISTICS A1. Applicability A2. Selectivity A3. Calibration and linearity A3.1 Linearity and intercept A3.2 Test for general matrix effect A3.3 Final calibration procedure

 

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