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:
Publisher: United Nations Publications
ISBN:
Category : Business & Economics
Languages : en
Pages : 76
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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.
Author:
Publisher: United Nations Publications
ISBN:
Category : Business & Economics
Languages : en
Pages : 76
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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.
Author: Ted Vosk
Publisher: CRC Press
ISBN: 143982620X
Category : Law
Languages : en
Pages : 457
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Book Description
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: Rosalind Wolstenholme
Publisher: John Wiley & Sons
ISBN: 1119978289
Category : Medical
Languages : en
Pages : 464
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Book Description
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: Serban C. Moldoveanu
Publisher: Elsevier
ISBN: 0443298505
Category : Science
Languages : en
Pages : 618
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Book Description
Method Development in Analytical HPLC presents the essential information for understanding the process of developing an HPLC method of analysis. It includes foundational information related to HPLC, as well as discussion of sample types, the properties of analytes and matrices in the samples, and sample preparation. The core of the book describes the best ways for approaching method development in various types of HPLC and the criteria for method optimization and validation. This book provides clear guidance for adopting analytical methods from the literature and describes the development of original methods with selection of the suitable type of HPLC, of specific columns, mobile phase, and detection techniques with an emphasis on the use of mass spectrometry for detection, as well as optimization and validation of the chosen analytical method. The book includes useful details on method development for specific types of chromatography such as RP-HPLC, HILIC, ion exchange, size exclusion, and chiral. Method Development in Analytical HPLC also includes information about green chemistry in analytical methods, computer assisted method development, and other key contemporary aspects of the subject. - Offers a systematic and logical presentation of the foundational of analytical HPLC - Goes in-depth on method development for specific types of chromatography such as RP-HPLC, HILIC, ion exchange, and size exclusion - Includes methods with an emphasis on the use of mass spectrometry for detection
Author: Eugenia Gallardo
Publisher: Frontiers Media SA
ISBN: 2889668940
Category : Science
Languages : en
Pages : 150
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Book Description
Author: Joe W. Simon
Publisher: Quality Press
ISBN: 1636940145
Category : Business & Economics
Languages : en
Pages : 251
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Book Description
As a quality professional in the medical device industry, you know all too well the importance of a risk management process-and how iterative it can be. Industry regulations and standards-like ISO 14971-help medical device manufacturers define risk management processes, but they don't make them bulletproof, that is, ensure the efficacy of their products while minimizing future liability. This book can help you build a bulletproof, risk process. You will learn how: Designing product and manufacturing processes controls risks Using consistent language in a holistic, closed-loop risk management system leads to greater efficiency Creating useable and audit-ready risk documents can support verification/validation (V/V) sampling plans Developing labels and instructions can help end-users and patients clearly understand the pertinent risks Creating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessary Joe Simon holds an MBA and has been a member of ASQ since 2008. Over his nearly 30-year career, he worked with numerous companies as an employee and a consultant to build or improve complaint analysis, trending, post-market surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes.
Author:
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 52
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Book Description
The quality of analyses and results of drug analysis laboratories have significant implications for the justice system, law enforcement, crime prevention and health policy, as well as for the international harmonization and worldwide exchange and coordination of drug information and data. The document aims to provide guidance to deliver high quality in a forensic laboratory, use the appropriate techniques to find the "answers" and to improve it constantly. It is a "how to do document" and includes some areas that are not explicitly covered in depth by ISO 17025.
Author: Omar Al Sayed Omar
Publisher: Walter de Gruyter GmbH & Co KG
ISBN: 3110528959
Category : Science
Languages : en
Pages : 501
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Book Description
During the past decade, modern high-performance liquid chromatography (HPLC) utilization has expanded greatly, especially in the quality control of pharmaceutical products in drug quality control laboratories. This book provides an extensive collection of technical information about HPLC-Columns (physicochemical properties and chromatographic characteristics), from various manufacturers, and helps analysts to decide on the ideal approach for their analysis according to the requirements of drug manufacturers specifi cations and the desired Pharmacopeia. In addition, the authors give practical advice on how to prepare mobile phases, choose a suitable detector, and set up an HPLC analysis. This book is comprehensive for the average professional or technician who plans to work with modern HPLC. This book is useful for most Drug Quality Control Laboratories where modern HPLC is utilized. Following a hands-on approach, the book gives key insights into the pharmaceutical applications of HPLC and the latest requirements of the major regulatory agencies such as ICH, FDA, or USP.
Author: Dhanasekharan Natarajan
Publisher: Springer
ISBN: 3319543830
Category : Technology & Engineering
Languages : en
Pages : 174
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Book Description
This book explains the requirements of ISO 9001 for establishing quality management system (QMS) for an organization. The requirements are illustrated with examples from industries for understanding the requirements and preparing the documents of QMS with high clarity. Methods of integrating ISO 9001 requirements with enterprise resource planning (ERP) software are presented. The software integrated approach enables process owners to focus on their core tasks of achieving the planned outputs of processes and the software generates quality records automatically.
Author: A. C. Moffat
Publisher:
ISBN:
Category : Analytical toxicology
Languages : en
Pages : 680
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Book Description
This manual and reference work provides a source of analytical data for drugs and related substances. It is intended for scientists faced with the difficult problem of identifying a drug in a pharmaceutical product, in a sample of tissue or body fluid, from a living patient or in post-mortem material. Volume One contains 32 chapters covering the practice of and analytical procedures used in forensic toxicology. Volume Two contains over 1750 drug and related substance monographs detailing: physical properties; analytical methods; pharmacokinetic data; and toxicity data, as well as expanded indexes and appendices. These volumes should be useful for all forensic and crime laboratories, toxicologists and analytical chemists, pathologists, poison information centres and clinical pharmacology departments.
