Validating chromatographic methods [[electronic resource] ] : a practical guide / / David M. Bliesner
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| Autore: |
Bliesner David M
|
| Titolo: |
Validating chromatographic methods [[electronic resource] ] : a practical guide / / David M. Bliesner
|
| Pubblicazione: | Hoboken, N.J., : Wiley, c2006 |
| Descrizione fisica: | 1 online resource (301 p.) |
| Disciplina: | 543.8 |
| 543/.8 | |
| Soggetto topico: | Chromatographic analysis - Validity |
| Science - Methodology | |
| Note generali: | Description based upon print version of record. |
| Nota di bibliografia: | Includes bibliographical references (p. 283) and index. |
| Nota di contenuto: | VALIDATING CHROMATOGRAPHIC METHODS; CONTENTS; PREFACE; 1. OVERVIEW OF METHODS VALIDATION; 2. COMPONENTS OF METHODS VALIDATION; 3. STEP 1: METHOD EVALUATION AND FURTHER DEVELOPMENT; 4. STEP 2: FINAL METHOD DEVELOPMENT AND TRIAL METHODS VALIDATION; 5. STEP 3: FORMAL METHODS VALIDATION AND REPORT GENERATION; 6. STEP 4: FORMAL DATA REVIEW AND REPORT ISSUANCE; 7. SUMMARY; APPENDICES; I. GLOSSARY OF METHODS VALIDATION TERMS; II. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION STANDARD OPERATING PROCEDURE (SOP); III. TEMPLATE FOR AN EXAMPLE END-USER REQUIREMENTS QUESTIONNAIRE |
| IV. TEMPLATE FOR AN EXAMPLE METHOD REVIEW CHECKLISTV. TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD; VI. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION PROTOCOL; VII. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION REPORT; REFERENCES; INDEX | |
| Sommario/riassunto: | All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal |
| Titolo autorizzato: | Validating chromatographic methods |
| ISBN: | 1-280-64898-8 |
| 9786610648986 | |
| 0-470-04220-6 | |
| 0-470-04219-2 | |
| Formato: | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione: | Inglese |
| Record Nr.: | 9910840587503321 |
| Lo trovi qui: | Univ. Federico II |
| Opac: | Controlla la disponibilità qui |