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Validating Chromatographic Methods – A Practical Guide +WS

Autor DM Bliesner
en Limba Engleză Hardback – 9 oct 2006
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 or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: * Method evaluation and further method development * Final method development and trial method validation * Formal method validation and report generation * Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a CD-ROM, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.
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Specificații

ISBN-13: 9780471741473
ISBN-10: 0471741477
Pagini: 304
Dimensiuni: 156 x 235 x 18 mm
Greutate: 0.56 kg
Editura: Wiley
Locul publicării:Hoboken, United States

Public țintă

Scientists responsible for chromatographic method development and validation and individuals with responsibility for laboratory management within the pharmaceutical industry. Also laboratories which are regulated by the government, namely: Facilities operating under Current Good Manufacturing Practices (CGMPs); Facilities operating under European Union (EU) requirements; and Facilities operating under ISO 9000 standards.

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Descriere

Validating Chromatographic Methods: A Practical Guide intends to bring order to the potentially chaotic process of methods validation. It provides the novice with enough practical information and tools to keep from having to reinvent the wheel by having to develop their own systems to attach methods validation from scratch.