Guidance For The Validation Of Analytical Methodology And Calibration Of Equipment Used For Testing Of Illicit Drugs In Seized Materials And Biological Specimens PDF Download
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Author | : United Nations |
Publisher | : United Nations Publications |
Total Pages | : 67 |
Release | : 2009 |
Genre | : Business & Economics |
ISBN | : 9789211482430 |
Download Guidance for the Validation of Analytical Methodology and Calibration of Equipment Used for Testing of Illicit Drugs in Seized Materials and Biological Specimens Book in PDF, ePub and Kindle
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.
Author | : Michael E. Swartz |
Publisher | : CRC Press |
Total Pages | : 218 |
Release | : 2012-04-24 |
Genre | : Medical |
ISBN | : 142001448X |
Download Handbook of Analytical Validation Book in PDF, ePub and Kindle
Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.
Author | : Aleš Fajgelj |
Publisher | : Royal Society of Chemistry |
Total Pages | : 328 |
Release | : 2000 |
Genre | : Science |
ISBN | : 9780854047833 |
Download Principles and Practices of Method Validation Book in PDF, ePub and Kindle
Analytical chemists and representatives of government agencies, standards organizations, and accreditation bodies involved in method validation gathered for an international workshop in November 1999 in Budapest to share experiences and work towards developing guidelines for validating analytical methods in general and specifically for determining pesticide and veterinary drug residues in food. The 18 lectures include discussions of validating analytical data in a research and development environment, the effects of sample processing on pesticide residues in fruits and vegetables, estimating the significance of matrix-induced chromatographic effects, and a worked example for validating a multi-residue method. Annotation copyrighted by Book News, Inc., Portland, OR
Author | : Chung Chow Chan |
Publisher | : John Wiley & Sons |
Total Pages | : 320 |
Release | : 2004-04-23 |
Genre | : Science |
ISBN | : 047146371X |
Download Analytical Method Validation and Instrument Performance Verification Book in PDF, ePub and Kindle
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.
Author | : Michael E. Swartz |
Publisher | : CRC Press |
Total Pages | : 95 |
Release | : 2018-10-03 |
Genre | : Science |
ISBN | : 1482229773 |
Download Analytical Method Development and Validation Book in PDF, ePub and Kindle
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.
Author | : Ludwig Huber |
Publisher | : CRC Press |
Total Pages | : 264 |
Release | : 1995-05-31 |
Genre | : Medical |
ISBN | : 9780935184754 |
Download Validation of Computerized Analytical Systems Book in PDF, ePub and Kindle
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.
Author | : Rosalind Wolstenholme |
Publisher | : John Wiley & Sons |
Total Pages | : 464 |
Release | : 2021-01-26 |
Genre | : Medical |
ISBN | : 1119978289 |
Download Analytical Techniques in Forensic Science Book in PDF, ePub and Kindle
An in-depth text that explores the interface between analytical chemistry and trace evidence Analytical Techniques in Forensic Science is a comprehensive guide written in accessible terms that examines the interface between analytical chemistry and trace evidence in forensic science. With contributions from noted experts on the topic, the text features a detailed introduction analysis in forensic science and then subsequent chapters explore the laboratory techniques grouped by shared operating principles. For each technique, the authors incorporate specific theory, application to forensic analytics, interpretation, forensic specific developments, and illustrative case studies. Forensic techniques covered include UV-Vis and vibrational spectroscopy, mass spectrometry and gas and liquid chromatography. The applications reviewed include evidence types such as fibers, paint, drugs and explosives. The authors highlight data collection, subsequent analysis, what information has been obtained and what this means in the context of a case. The text shows how analytical chemistry and trace evidence can problem solve the nature of much of forensic analysis. This important text: Puts the focus on trace evidence and analytical science Contains case studies that illustrate theory in practice Includes contributions from experts on the topics of instrumentation, theory, and case examples Explores novel and future applications for analytical techniques Written for undergraduate and graduate students in forensic chemistry and forensic practitioners and researchers, Analytical Techniques in Forensic Science offers a text that bridges the gap between introductory textbooks and professional level literature.
Author | : Ted Vosk |
Publisher | : CRC Press |
Total Pages | : 457 |
Release | : 2014-09-26 |
Genre | : Law |
ISBN | : 143982620X |
Download Forensic Metrology Book in PDF, ePub and Kindle
Forensic metrology is the application of scientific measurement to the investigation and prosecution of crime. Forensic measurements are relied upon to determine breath and blood alcohol and drug concentrations, weigh seized drugs, perform accident reconstruction, and for many other applications. Forensic metrology provides a basic framework for th
Author | : |
Publisher | : |
Total Pages | : 34 |
Release | : 1988 |
Genre | : Drugs |
ISBN | : |
Download Guideline for Submitting Samples and Analytical Data for Methods Validation Book in PDF, ePub and Kindle
Author | : NVLAP (Program : U.S.) |
Publisher | : |
Total Pages | : 398 |
Release | : 1994 |
Genre | : Calibration |
ISBN | : |
Download National Voluntary Laboratory Accreditation Program Book in PDF, ePub and Kindle