Analytical Method Validation and Instrument Performance Verification
Title | Analytical Method Validation and Instrument Performance Verification PDF eBook |
Author | Chung Chow Chan |
Publisher | John Wiley & Sons |
Pages | 320 |
Release | 2004-04-23 |
Genre | Science |
ISBN | 047146371X |
Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
Validation of Computerized Analytical Systems
Title | Validation of Computerized Analytical Systems PDF eBook |
Author | Ludwig Huber |
Publisher | CRC Press |
Pages | 268 |
Release | 2023-04-28 |
Genre | Science |
ISBN | 1000948226 |
Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details. International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
VALIDATION OF COMPUTERIZED ANALYTICAL AND NETWORKED SYSTEMS
Title | VALIDATION OF COMPUTERIZED ANALYTICAL AND NETWORKED SYSTEMS PDF eBook |
Author | LUDWIG HUBER. |
Publisher | |
Pages | |
Release | 2001 |
Genre | |
ISBN | 9780429135927 |
Preparing for FDA Pre-Approval Inspections
Title | Preparing for FDA Pre-Approval Inspections PDF eBook |
Author | Martin D. Hynes |
Publisher | CRC Press |
Pages | 310 |
Release | 2016-04-19 |
Genre | Medical |
ISBN | 1000654370 |
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th
Modern HPLC for Practicing Scientists
Title | Modern HPLC for Practicing Scientists PDF eBook |
Author | Michael W. Dong |
Publisher | John Wiley & Sons |
Pages | 285 |
Release | 2016-04-06 |
Genre | Science |
ISBN | 111929360X |
A comprehesive yet concise guide to Modern HPLC Written for practitioners by a practitioner, Modern HPLC for Practicing Scientists is a concise text which presents the most important High-Performance Liquid Chromatography (HPLC) fundamentals, applications, and developments. It describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. Moreover, the book serves well as an updated reference guide for busy laboratory analysts and researchers. Topics covered include: HPLC operation Method development Maintenance and troubleshooting Modern trends in HPLC such as quick-turnaround and "greener" methods Regulatory aspects While broad in scope, this book focuses particularly on reversed-phase HPLC, the most common separation mode, and on applications for the pharmaceutical industry, the largest user segment. Accessible to both novice and intermedate HPLC users, information is delivered in a straightforward manner illustrated with an abundance of diagrams, chromatograms, tables, and case studies, and supported with selected key references and Web resources. With intuitive explanations and clear figures, Modern HPLC for Practicing Scientists is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology.
High Performance Liquid Chromatography
Title | High Performance Liquid Chromatography PDF eBook |
Author | Omar Al Sayed Omar |
Publisher | Walter de Gruyter GmbH & Co KG |
Pages | 322 |
Release | 2022-02-21 |
Genre | Science |
ISBN | 3110529459 |
The book provides an indispensable guide on how to use HPLC in pharmaceutical analysis and drug control. Following a hands-on approach, the authors give practical advices how to prepare stationary and mobile phases, choose a suitable detector and set up an HPLC analysis. The publication gives insight into the key pharmaceutical applications of HPLC and the latest requirements of the major regulatory agencies.
Scientific and Technical Aerospace Reports
Title | Scientific and Technical Aerospace Reports PDF eBook |
Author | |
Publisher | |
Pages | 464 |
Release | 1995 |
Genre | Aeronautics |
ISBN |