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General Requirements For The Competence Of Reference Material Producers
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Book Synopsis Reference Materials in Analytical Chemistry by : A. Zschunke
Download or read book Reference Materials in Analytical Chemistry written by A. Zschunke and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Under the guidance of the German Federal Institute for Materials Research (BAM), the standards for fabrication and application of reference materials are presented here in comprehensive form. The areas covered are analytical chemistry, materials science, environmental analysis, clinical and forensic toxicological analysis, and gas and food analysis. A standard reference for every analytical laboratory.
Book Synopsis GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) by : Leonard Steinborn
Download or read book GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) written by Leonard Steinborn and published by CRC Press. This book was released on 2004-12-30 with total page 453 pages. Available in PDF, EPUB and Kindle. Book excerpt: This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa
Book Synopsis Handbook of Metrology and Applications by : Dinesh K. Aswal
Download or read book Handbook of Metrology and Applications written by Dinesh K. Aswal and published by Springer Nature. This book was released on 2023-08-23 with total page 2504 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook provides comprehensive and up-to-date information on the topic of scientific, industrial and legal metrology. It discusses the state-of-art review of various metrological aspects pertaining to redefinition of SI Units and their implications, applications of time and frequency metrology, certified reference materials, industrial metrology, industry 4.0, metrology in additive manufacturing, digital transformations in metrology, soft metrology and cyber security, optics in metrology, nano-metrology, metrology for advanced communication, environmental metrology, metrology in biomedical engineering, legal metrology and global trade, ionizing radiation metrology, advanced techniques in evaluation of measurement uncertainty, etc. The book has contributed chapters from world’s leading metrologists and experts on the diversified metrological theme. The internationally recognized team of editors adopt a consistent and systematic approach and writing style, including ample cross reference among topics, offering readers a user-friendly knowledgebase greater than the sum of its parts, perfect for frequent consultation. Moreover, the content of this volume is highly interdisciplinary in nature, with insights from not only metrology but also mechanical/material science, optics, physics, chemistry, biomedical and more. This handbook is ideal for academic and professional readers in the traditional and emerging areas of metrology and related fields.
Book Synopsis Environmental Toxicology by : Luis M. Botana
Download or read book Environmental Toxicology written by Luis M. Botana and published by Walter de Gruyter GmbH & Co KG. This book was released on 2024-03-18 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book about Non-bacterial toxins will cover those toxins that affect food safety and are produced by fungi (mycotoxins), cyanobacteria (cyanotoxins) and marine microalgae (phycotoxins). These three group of toxins affect food safety and drinking water quality at a global scale, and they pose three main challenges for scientists: 1) Climate change is causing a slow but steady change on the chemical profile of each of these groups, causing intoxications in areas that are geographically new to the intoxications map. For this reason, emerging toxins are a new topic that requires an important reallocation of resources to understand the new toxins trends, their toxicology, their analytical control and how to deal with them from a regulatory standpoint. 2) Toxicological science needs to be updated to determine the impact of the toxins in all kind of vectors (more and more are being discovered) and how they disseminate on the food chain. Also, the mode of action of many of this toxins is not understood or even known, and this affects also to the impact of the coexistence of several toxins in the same matrix. 3) Detection and regulation, as this requires the use of advance technology (mass spectrometry, biosensors, multitask screening etc) that is in many cases underdevelopped or not available, especially for many of the new toxins. Climate change, toxicology and detection affect so many areas of science that this book will try to keep the readers updated about the current state of the art.
Book Synopsis Applications of Reference Materials in Analytical Chemistry by : Ron Walker
Download or read book Applications of Reference Materials in Analytical Chemistry written by Ron Walker and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reference materials play an important role in analytical chemistry, where they are used by analysts for a variety of purposes, including: checking and calibrating instruments; validating methods and estimating the uncertainty of analytical measurements; checking laboratory and analyst performance; and internal quality control. This book provides guidance and information for the users of certified reference materials (CRMs), explaining how they can best be used to achieve valid analytical measurements and improve quality in the analytical laboratory. General information on CRMs and how they are produced sets the scene for readers. The statistics relating to CRM use are then explained in an easy-to-understand manner, and this is followed by sections covering the main uses of CRMs. Detailed worked examples are used throughout. Structured and comprehensive in coverage, this book will be welcomed by all users of certified reference materials.
Book Synopsis Reference Materials for Chemical Analysis by : Markus Stoeppler
Download or read book Reference Materials for Chemical Analysis written by Markus Stoeppler and published by John Wiley & Sons. This book was released on 2008-07-11 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are many academic references describing how RMs are made, but few that explain why they are used, how they should be used and what happens when they are not properly used. In order to fill this gap, the editors have taken the contributions of more than thirty RM practitioners to produce a highly readable text organized in nine chapters. Starting with an introduction to historical, theoretical and technical requirements, the book goes on to examine all aspects of RM production from planning, preparation through analysis to certification, reviews recent development areas, RMs for life analysis and some important general application fields, considers the proper usage of RMs, gives advice on availability and sources of information and lastly looks at future trends and needs for RMs. This book is intended to be a single point of information that both guides the reader through the use of RMs and serves as a primary reference source. It should be on the reading list of anyone working in an analytical laboratory and be found on the library shelf of all analytical chemical laboratories.
Book Synopsis Reference Materials in Measurement and Technology by : Sergey V. Medvedevskikh
Download or read book Reference Materials in Measurement and Technology written by Sergey V. Medvedevskikh and published by Springer Nature. This book was released on 2022-07-18 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book covers in particular state-of-the-art scientific research about product quality control and related health and environmental safety topics, including human, animal and plant safety assurance issues. These conference proceedings provide contemporary information on the general theoretical, metrological and practical issues of the production and application of reference materials. Reference materials play an integral role in physical, chemical and related type of measurements, ensuring their uniformity, comparability and the validity of quantitative analysis as well as, as a result, the objectivity of decisions concerning the elimination of technical barriers in commercial and economic, scientific and technical and other spheres of cooperation. The book is intended for researchers and practitioners in the field of chemistry, metrologists, technical physics, as well as for specialists in analytical laboratories, or working for companies and organizations involved in the production, distribution and use of reference materials.
Book Synopsis Quality Assurance and Quality Control in the Analytical Chemical Laboratory by : Piotr Konieczka
Download or read book Quality Assurance and Quality Control in the Analytical Chemical Laboratory written by Piotr Konieczka and published by CRC Press. This book was released on 2018-03-26 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition defines the tools used in QA/QC, especially the application of statistical tools during analytical data treatment. Clearly written and logically organized, it takes a generic approach applicable to any field of analysis. The authors begin with the theory behind quality control systems, then detail validation parameter measurements, the use of statistical tests, counting the margin of error, uncertainty estimation, traceability, reference materials, proficiency tests, and method validation. New chapters cover internal quality control and equivalence method, changes in the regulatory environment are reflected throughout, and many new examples have been added to the second edition.
Book Synopsis Meeting the mycotoxin menace by : D. Barug
Download or read book Meeting the mycotoxin menace written by D. Barug and published by BRILL. This book was released on 2023-08-28 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Mycotoxins are toxic secondary metabolites of moulds belonging essentially to the Aspergillus, Penicillium, and Fusarium genera. They can be produced on a wide range of agricultural commodities and under a diverse range of situations. Due to their various toxic effects and their good thermal stability, the presence of mycotoxins in foods and feeds is potentially hazardous to the health of both humans and animals. Mycotoxins may cause damage to e.g. liver, kidney or the nervous system, some are even carcinogenic. There is growing concern for ways in which these fungi and their mycotoxins can be prevented from entering the human and animal food chain. And worldwide changes in legislation ever increase the need for more precise and sensitive mycotoxin analytical methods. 'Meeting the mycotoxin menace' contains the peer-reviewed papers of the second World Mycotoxin Forum held 17-18 February 2003 in Noordwijk, the Netherlands. The book focuses on the various aspects related to the presence, prevention, control, sampling and analysis of mycotoxins in agricultural commodities, foods and feeds. In this publication special attention is given to new developments in this field. The editors firmly believe that the very nature of the themes chosen and the excellence of the papers by invited experts from various disciplines will draw an audience from both the food and feed industry, regulatory authorities and science."
Book Synopsis Analytical Chemistry by : E. Hywel Evans
Download or read book Analytical Chemistry written by E. Hywel Evans and published by Oxford University Press. This book was released on 2019 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analytical Chemistry: A Practical Approach is the only chemical analysis text with an emphasis on active learning, giving students step-by-step guidance on how the key principles of analytical science are applied in a range of practical, real-world contexts.
Book Synopsis Engineering Surveys for Industry by : Alojz Kopáčik
Download or read book Engineering Surveys for Industry written by Alojz Kopáčik and published by Springer Nature. This book was released on 2020-07-22 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the translated English version of a text on industrial surveys, originally published in Slovak by SPEKTRUM STU Publishing. This updated version is not only a translation of the original, but also a reviewed, extended version, which reflects up-to-date international standards and regulations. The book covers topics in engineering surveying not available in other publications in this complex form, and addresses the design methodology, data processing and implementation of geodetic measurements under specific conditions to make industrial work environments safer and more efficient. The book begins by introducing readers to these conditions, and then discusses design of maps, geodetic networks and information systems of industrial plants, the usage of cartesian and polar coordinate measuring systems, terrestrial laser scanning technology, as well as measurement of cranes, rotary kilns and special objects of nuclear power plants. The book will be of use to teachers, students, practitioners (e.g. surveyors), quality production managers, equipment designers and mechanical engineers.
Book Synopsis Quality Management in Forensic Science by : Sean Doyle
Download or read book Quality Management in Forensic Science written by Sean Doyle and published by Academic Press. This book was released on 2018-11-20 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: Forensic science has been under scrutiny for some time, since the release of the NAS report in 2009. The report cited the need for standardized practices and the accreditation of crime labs. No longer can the forensic community take the position that cross-examination in a courtroom will expose weaknesses in methodology and execution. Quality Management in Forensic Science covers a wide spectrum of forensic disciplines, relevant ISO and non-ISO standards, accreditation and quality management systems necessary in any forensic science laboratory. Written by a globally well-respected forensic scientist with decades of experience in the forensic science laboratory and on the stand, as an expert witness who is also a Fellow of both the Royal Society of Chemistry and the Chartered Society of Forensic Sciences. This book will be a must-have resource for all forensic science stakeholders, particularly law enforcement agents and lawyers less familiar with the impact of quality management on the reliability of scientific evidence. - A comprehensive, multidisciplinary reference of scientific practices for use in the forensic laboratory - Coverage from DNA to toxicology, from trace evidence to crime scene and beyond - Extensive review of ISO and non-ISO standards, accreditation, QMS and much more - Written by a foremost forensic scientist with decades of experience in the laboratory and as an expert witness
Book Synopsis Quality Assurance for Water Analysis by : Philippe Quevauviller
Download or read book Quality Assurance for Water Analysis written by Philippe Quevauviller and published by John Wiley & Sons. This book was released on 2008-04-30 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance (QA) has become an increasingly important topic, as environmental monitoring bodies realize that accuracy of measurements can depend very much on how the measurement is taken. This book will describe methods in light of all of the European, US, and international (ISO) guidelines for QA of water analysis. It is the third book in the Water Quality Measurement Series, it tackles the growing problem of developing an international understanding for measurement and data collection. The author gives a detailed overview of: * The purpose of water analysis * Quality systems and quality control * Sources of error including sample contamination * Method validation * Certified reference materials * Data Reporting * Inter-laboratory studies
Book Synopsis Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection by : World Health Organization
Download or read book Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection written by World Health Organization and published by World Health Organization. This book was released on 2024-01-31 with total page 1354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.
Book Synopsis Encyclopedia of Food Microbiology by : Carl A. Batt
Download or read book Encyclopedia of Food Microbiology written by Carl A. Batt and published by Academic Press. This book was released on 2014-04-02 with total page 3243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by the world's leading scientists and spanning over 400 articles in three volumes, the Encyclopedia of Food Microbiology, Second Edition is a complete, highly structured guide to current knowledge in the field. Fully revised and updated, this encyclopedia reflects the key advances in the field since the first edition was published in 1999 The articles in this key work, heavily illustrated and fully revised since the first edition in 1999, highlight advances in areas such as genomics and food safety to bring users up-to-date on microorganisms in foods. Topics such as DNA sequencing and E. coli are particularly well covered. With lists of further reading to help users explore topics in depth, this resource will enrich scientists at every level in academia and industry, providing fundamental information as well as explaining state-of-the-art scientific discoveries. This book is designed to allow disparate approaches (from farmers to processors to food handlers and consumers) and interests to access accurate and objective information about the microbiology of foods Microbiology impacts the safe presentation of food. From harvest and storage to determination of shelf-life, to presentation and consumption. This work highlights the risks of microbial contamination and is an invaluable go-to guide for anyone working in Food Health and Safety Has a two-fold industry appeal (1) those developing new functional food products and (2) to all corporations concerned about the potential hazards of microbes in their food products
Book Synopsis Ensuring Quality to Gain Access to Global Markets by : Martin Kellermann
Download or read book Ensuring Quality to Gain Access to Global Markets written by Martin Kellermann and published by World Bank Publications. This book was released on 2019-04-09 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a modern world with rapidly growing international trade, countries compete less based on the availability of natural resources, geographical advantages, and lower labor costs and more on factors related to firms' ability to enter and compete in new markets. One such factor is the ability to demonstrate the quality and safety of goods and services expected by consumers and confirm compliance with international standards. To assure such compliance, a sound quality infrastructure (QI) ecosystem is essential. Jointly developed by the World Bank Group and the National Metrology Institute of Germany, this guide is designed to help development partners and governments analyze a country's quality infrastructure ecosystems and provide recommendations to design and implement reforms and enhance the capacity of their QI institutions.
Book Synopsis Specification of Drug Substances and Products by : Christopher M. Riley
Download or read book Specification of Drug Substances and Products written by Christopher M. Riley and published by Elsevier. This book was released on 2024-09-22 with total page 910 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals. There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines. This edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the 2nd edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products - Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions. - Addresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug–device combination products such as digital drug delivery systems, transdermal systems, and inhalation products. - Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data).