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Le Profil Dexactitude Une Approche Integree Pour La Validation Des Methodes Physico Chimiques Dans Lindustrie Pharmaceutique
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Author :Food and Agriculture Organization of the United Nations. Inland Water Resources and Aquaculture Service Publisher :Food & Agriculture Org. ISBN 13 :9789251056318 Total Pages :148 pages Book Rating :4.0/5 (563 download)
Book Synopsis State of World Aquaculture 2006 by : Food and Agriculture Organization of the United Nations. Inland Water Resources and Aquaculture Service
Download or read book State of World Aquaculture 2006 written by Food and Agriculture Organization of the United Nations. Inland Water Resources and Aquaculture Service and published by Food & Agriculture Org.. This book was released on 2006 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aquaculture is developing, expanding and intensifying in almost all regions of the world, except in sub-Saharan Africa. Although the sector appears to be capable of meeting the gap between future demand and supply for aquatic food, there are many constraints and challenges which must be addressed in order to at least maintain the present level of per capita consumption at the global level. Key issues are the need for enhanced enforcement of regulation and better governance of the sector, as well as greater producer participation in the decision-making and regulation process. This publication examines past trends in aquaculture development as well as the current global status, drawing on a number of national and regional reviews.
Book Synopsis Faecal Sludge Management by : Linda Strande
Download or read book Faecal Sludge Management written by Linda Strande and published by IWA Publishing. This book was released on 2014-08-15 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is estimated that literally billions of residents in urban and peri-urban areas of Africa, Asia, and Latin America are served by onsite sanitation systems (e.g. various types of latrines and septic tanks). Until recently, the management of faecal sludge from these onsite systems has been grossly neglected, partially as a result of them being considered temporary solutions until sewer-based systems could be implemented. However, the perception of onsite or decentralized sanitation technologies for urban areas is gradually changing, and is increasingly being considered as long-term, sustainable options in urban areas, especially in low- and middle-income countries that lack sewer infrastructures. This is the first book dedicated to faecal sludge management. It compiles the current state of knowledge of the rapidly evolving field of faecal sludge management, and presents an integrated approach that includes technology, management, and planning based on Sandecs 20 years of experience in the field. Faecal Sludge Management: Systems Approach for Implementation and Operation addresses the organization of the entire faecal sludge management service chain, from the collection and transport of sludge, and the current state of knowledge of treatment options, to the final end use or disposal of treated sludge. The book also presents important factors to consider when evaluating and upscaling new treatment technology options. The book is designed for undergraduate and graduate students, and engineers and practitioners in the field who have some basic knowledge of environmental and/or wastewater engineering.
Book Synopsis How to Design Wastewater Systems for Local Conditions in Developing Countries by : David M. Robbins
Download or read book How to Design Wastewater Systems for Local Conditions in Developing Countries written by David M. Robbins and published by IWA Publishing. This book was released on 2014-03-15 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a practical handbook providing a step-by-step approach to the techniques used for characterizing wastewater sources and investigating sites where collection, treatment and reuse/disposal technologies will be installed. It is intended to help enable local implementation of on-site and decentralized wastewater management system (DWMS)for wide scale use in development settings. How to Design Wastewater Systems for Local Conditions in Developing Countries helps local service providers and regulatory officials make informed decisions through the use of tools, checklists and case studies. It includes a link to a web based community of on-site and decentralized wastewater professionals, which contains related tools and case studies. This handbook serves as a reference for training classes, certification programs, and higher education programs in civil and sanitary engineering. There is an increasing interest on the part of local government officials and private sector service providers to implement wastewater treatment systems to solve sanitation problems. The model presented in this handbook promotes activities that first generate data related to source and site conditions that represent critical inputs, and then applies this information to the technology selection process. Matching the most appropriate technologies to the specific needs of the wastewater project is the key that leads to long term sustainability. How to Design Wastewater Systems for Local Conditions in Developing Countries is an invaluable resource for public sector decision makers and private sector service providers in developing countries. It is also a useful text for students at engineering colleges in developing countries interested in taking a class that teaches the methods of decentralized wastewater management system (DWMS) development.
Book Synopsis Biotechnology and Sustainable Development by : Ismail Serageldin
Download or read book Biotechnology and Sustainable Development written by Ismail Serageldin and published by CABI. This book was released on 2003 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on the first scientific conference convened at the Library of Alexandria, 'Biotechnology and Sustainable Development: Voices of the South and North', which was held in Alexandria, Egypt, in March 2002, this book contains overviews of agriculture, health, ethics and the environment. It discusses how dramatic improvements in food security, health, and lifestyle could accrue to the poor people of developing countries through the applications of new technologies.
Book Synopsis Compendium of Sanitation Systems and Technologies by : Elizabeth Tilley
Download or read book Compendium of Sanitation Systems and Technologies written by Elizabeth Tilley and published by . This book was released on 2014 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Flexoelectricity in Liquid Crystals by : Agnes Buka
Download or read book Flexoelectricity in Liquid Crystals written by Agnes Buka and published by World Scientific. This book was released on 2013 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book intends to give a state-of-the-art overview of flexoelectricity, a linear physical coupling between mechanical (orientational) deformations and electric polarization, which is specific to systems with orientational order, such as liquid crystals. Chapters written by experts in the field shed light on theoretical as well as experimental aspects of research carried out since the discovery of flexoelectricity. Besides a common macroscopic (continuum) description the microscopic theory of flexoelectricity is also addressed. Electro-optic effects due to or modified by flexoelectricity as well as various (direct and indirect) measurement methods are discussed. Special emphasis is given to the role of flexoelectricity in pattern-forming instabilities. While the main focus of the book lies in flexoelectricity in nematic liquid crystals, peculiarities of other mesophases (bent-core systems, cholesterics, and smectics) are also reviewed. Flexoelectricity has relevance to biological (living) systems and can also offer possibilities for technical applications. The basics of these two interdisciplinary fields are also summarized.
Book Synopsis Tristes Tropiques by : Claude Levi-Strauss
Download or read book Tristes Tropiques written by Claude Levi-Strauss and published by Penguin. This book was released on 2012-01-31 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A magical masterpiece."—Robert Ardrey. A chronicle of the author's search for a civilization "reduced to its most basic expression."
Book Synopsis Nonlinear Optical Materials by : Jerome V. Moloney
Download or read book Nonlinear Optical Materials written by Jerome V. Moloney and published by Springer Science & Business Media. This book was released on 1998-08-13 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mathematical methods play a significant role in the rapidly growing field of nonlinear optical materials. This volume discusses a number of successful or promising contributions. The overall theme of this volume is twofold: (1) the challenges faced in computing and optimizing nonlinear optical material properties; and (2) the exploitation of these properties in important areas of application. These include the design of optical amplifiers and lasers, as well as novel optical switches. Research topics in this volume include how to exploit the magnetooptic effect, how to work with the nonlinear optical response of materials, how to predict laser-induced breakdown in efficient optical devices, and how to handle electron cloud distortion in femtosecond processes.
Book Synopsis Practical Approaches to Method Validation and Essential Instrument Qualification by : Chung Chow Chan
Download or read book Practical Approaches to Method Validation and Essential Instrument Qualification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2011-03-01 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
Book Synopsis Analytical Method Validation and Instrument Performance Verification by : Chung Chow Chan
Download or read book Analytical Method Validation and Instrument Performance Verification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2004-04-23 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Validation in Chemical Measurement by : Paul De Bièvre
Download or read book Validation in Chemical Measurement written by Paul De Bièvre and published by Springer Science & Business Media. This book was released on 2005-12-06 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance." They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the user of the measurement results.
Book Synopsis Calibration and Validation of Analytical Methods by : Mark Stauffer
Download or read book Calibration and Validation of Analytical Methods written by Mark Stauffer and published by BoD – Books on Demand. This book was released on 2018-04-25 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Development and Validation of Analytical Methods by : Christopher M. Riley
Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Book Synopsis Handbook of Analytical Validation by : Michael E. Swartz
Download or read book Handbook of Analytical Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2012-04-24 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Robustness of Analytical Chemical Methods and Pharmaceutical Technological Products by : M.M.W.B. Hendriks
Download or read book Robustness of Analytical Chemical Methods and Pharmaceutical Technological Products written by M.M.W.B. Hendriks and published by Elsevier. This book was released on 1996-12-11 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: In analytical chemistry and pharmaceutical technology attention is increasingly focussed on improving the quality of methods and products. This book aims at fostering the awareness of the potential of existing mathematical and statistical methods to improve this quality. It provides procedures and ideas on how to make a product or a method less sensitive to small variations in influencing factors. Major issues covered are robustness and stability improvement and ruggedness testing. General strategies and a theoretical introduction to these methods are described, and thorough overviews of methods used in both application areas and descriptions of practical applications are given.Features of this book:• Gives a good overview of mathematical and statistical methods used in two application areas, i.e. pharmaceutical technology and analytical chemistry• Illustrates the different approaches available to attain robustness• Gives ideas on how to use methods in practical situations.The book is intended for those who develop and optimize, and are responsible for the overall quality of, analytical methods and pharmaceutical technological products and procedures.
Book Synopsis La méthode de calcul des Limites Résiduelles Acceptables : un pilier de l'optimisation de la stratégie de la validation de nettoyage dans l'industrie pharmaceutique by : Fanny Dupuy
Download or read book La méthode de calcul des Limites Résiduelles Acceptables : un pilier de l'optimisation de la stratégie de la validation de nettoyage dans l'industrie pharmaceutique written by Fanny Dupuy and published by . This book was released on 2024 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dans l'industrie pharmaceutique, le nettoyage représente un pilier fondamental dans la lutte contre les contaminations des produits fabriqués. Afin d'évaluer l'efficacité de cette opération la stratégie de validation de nettoyage est particulièrement importante. Cela passe notamment par le choix de seuils d'acceptation adaptés et pertinents (prise en compte de la Permitted Daily Exposure (PDE), de la surface réelle des équipements...). Ce travail expose donc dans un premier temps, les différents modes de contamination et les différents moyens mis en œuvre pour les éviter. Puis, il détaille les pré requis à la validation de nettoyage ainsi que ses diverses étapes. Pour finir, il présente un exemple concret d'optimisation de stratégie de validation de nettoyage via le calcul de nouvelles Limites Résiduelles Acceptables (LRA) et le choix de nouveaux critères d'acceptation.
Book Synopsis La validation de méthode en spectrométrie d’émission optique à source plasma by : CETAMA
Download or read book La validation de méthode en spectrométrie d’émission optique à source plasma written by CETAMA and published by EDP Sciences. This book was released on 2017-11-02T00:00:00+01:00 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: L’analyse élémentaire a connu des développements instrumentaux majeurs depuis les années 70. C’est tout particulièrement le cas avec la spectrométrie d’émission atomique à source plasma (ICP-OES), commercialisée pour la première fois en 1974, et qui s’est rapidement imposée en se déployant très largement dans les laboratoires de caractérisation. Bien que l’ICP-OES soit devenue une technique d’analyse de routine, les exigences de la mesure imposent une maîtrise complète du processus opératoire et du système de management de la qualité associé. L’objectif de cet ouvrage est de guider l’analyste durant tout le processus de validation de sa mesure et de l’aider à garantir la maîtrise de ses principales étapes : gestion administrative et physique des échantillons au laboratoire ; préparation et traitement de ceux-ci avant mesure ; qualification et suivi de l’appareillage ; réglages instrumentaux et stratégie d’étalonnage ; exploitation des résultats en termes de justesse, fidélité, incertitude et exactitude (avec la détermination pratique du « profil d’exactitude »). Le guide s’appuie pour cela sur la terminologie la plus actuelle et sur de nombreux exemples et illustrations destinés à faciliter la compréhension et la constitution des dossiers de validation de méthode. Cet ouvrage collectif a été constitué dans le cadre des travaux de la Commission d’ÉTAblissement des Méthodes d’Analyses du Commissariat à l’Énergie Atomique et aux Énergies Alternatives. Trente-huit spécialistes de l’ICP-OES, travaillant dans des laboratoires de recherches de grands organismes (AREVA, ARKEMA, CEA, C2RMF, EDF, EURODIF, IRSN) et d’Universités (Université de Pau et des Pays de l’Adour, Université Claude Bernard Lyon 1), y ont contribué durant plus de dix ans.
