Author: Publisher:
ISBN:
Category : Drug approval
Languages : en
Pages :
Book Description
Guidelines for Submitting Samples and Analytical Data for Methods Validation
Author: Guideline for Submitting Samples and Analytical Data for Methods Validation
Author: Analytical Method Development and Validation
Author: Michael E. SwartzPublisher: CRC Press
ISBN: 1482229773
Category : Science
Languages : en
Pages : 95
Book Description
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Guideline on General Principles of Process Validation
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
Book Description
Calibration and Validation of Analytical Methods
Author: Mark StaufferPublisher: BoD – Books on Demand
ISBN: 1789230845
Category : Science
Languages : en
Pages : 176
Book Description
This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, "Introduction," contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 "Calibration Approaches" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in this section provides a segue into Section 3, "Validation Approaches," which contains two chapters on validation procedures and parameters. This book is a valuable source of scientific information for anyone interested in analytical calibration and validation.
Guidance for the Validation of Analytical Methodology and Calibration of Equipment Used for Testing of Illicit Drugs in Seized Materials and Biological Specimens
Author: United NationsPublisher: United Nations Publications
ISBN: 9789211482430
Category : Business & Economics
Languages : en
Pages : 67
Book Description
The validation of analytical methods and the calibration of equipment are important aspects of quality assurance in the laboratory. This manual deals with both of these within the context of testing of illicit drugs in seized materials and biological specimens. It provides an introduction and practical guidance to national authorities and analysts in the implementation of method validation and verification, and also in the calibration/performance verification of laboratory instrumentation and equipment within their existing internal quality assurance programmes. The procedures described represent a synthesis of the experience of scientists from several reputable laboratories around the world.
Text on Validation of Analytical Procedures
Author: Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 16
Book Description
NIOSH Manual of Analytical Methods: NIOSH monitoring methods
Author: John V. CrablePublisher:
ISBN:
Category : Analytical chemistry
Languages : en
Pages : 816
Book Description
Validating Chromatographic Methods
Author: David M. BliesnerPublisher: John Wiley & Sons
ISBN: 0470042192
Category : Science
Languages : en
Pages : 301
Book Description
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 supplementary support site, 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.
FDA Nutrition Labeling Manual
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Database design
Languages : en
Pages : 152
Book Description
Gives generic instructions for developing and preparing an acceptable data base when valid estimates of nutrient content and variation are not available for the food (single or mixed products) to be labeled. The purpose of the manual is to advise the food industry in developing nutrition labels for food products that must comply with the regulations and to assist health professionals in interpreting nutrition labels on food products.
