Validating Chromatographic Methods: A Practical Guide

PREFACE vii

1. OVERVIEW OF METHODS VALIDATION 1

2. COMPONENTS OF METHODS VALIDATION 8

3. STEP 1: METHOD EVALUATION AND FURTHER DEVELOPMENT 15

4. STEP 2: FINAL METHOD DEVELOPMENT AND TRIAL METHODS VALIDATION 28

5. STEP 3: FORMAL METHODS VALIDATION AND REPORT GENERATION 41

6. STEP 4: FORMAL DATA REVIEW AND REPORT ISSUANCE 48

7. SUMMARY 55

APPENDICES

I. GLOSSARY OF METHODS VALIDATION TERMS 57

II. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION STANDARD OPERATING

PROCEDURE (SOP) 72

III. TEMPLATE FOR AN EXAMPLE END-USER REQUIREMENTS QUESTIONNAIRE 154

IV. TEMPLATE FOR AN EXAMPLE METHOD REVIEW CHECKLIST 156

V. TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD 159

VI. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION PROTOCOL 169

VII. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION REPORT 218

REFERENCES 283

INDEX 285