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Practical Approaches to Method Validation and Essential Instrument Qualification.
Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirementsComplementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additiona...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken :
John Wiley & Sons,
2011.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Cover; Title Page; Copyright Page; Preface; Contributors; Chapter 1: Overview of Risk-Based Approach to Phase Appropriate Validation and Instrument Qualification; Chapter 2: Phase Appropriate Method Validation; Chapter 3: Analytical Method Verification, Method Revalidation, and Method Transfer; Chapter 4: Validation of Process Analytical Technology Applications; Chapter 5: Validation of Near-Infrared Systems for Raw Material Identification; Chapter 6: Cleaning Validation; Chapter 7: Risk-Based Validation of Laboratory Information Management Systems.
- Chapter 8: Performance Qualification and Verification of BalanceChapter 9: Performance Verification of NIR Spectrophotometers; Chapter 10: OPERATIONAL QUALIFICATION IN PRACTICE FOR GAS CHROMATOGRAPHY INSTRUMENTS; Chapter 11: Performance Verification on Refractive Index, Fluorescence, and Evaporative Light-Scattering Detection; Chapter 12: Instrument qualification and performance verification for particle size instruments; Chapter 13: Method Validation, Qualification, and Performance Verification for Total Organic Carbon Analyzers; Chapter 14: Instrument Performance Verification: MicroPipettes.
- Chapter 15: Instrument Qualification and Performance Verification for Automated Liquid-Handling SystemsChapter 16: Performance Qualification and Verification in Powder X-Ray Diffraction; Index.