Download or read book The Fitness for Purpose of Analytical Methods written by and published by . This book was released on 1998-01-01 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Download or read book Valid Analytical Methods and Procedures written by Chris Burgess and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Analytical Methods Committee of the Royal Society of Chemistry has for many years been involved in national and international efforts to establish a comprehensive framework for achieving appropriate quality in chemical measurement. This handbook attempts to select or define robust procedures that ensure the best use of resources and enable laboratories to generate consistent, reliable data. Written in concise, easy-to-read language and illustrated with worked examples, it is a guide to current best practice and establishes a control framework for the development and validation of laboratory-based analytical methods. Topics include samples and sampling, method selection, equipment calibration and qualification, method development and validation, evaluation of data and statistical approaches for method performance and comparison. Valid Analytical Methods and Procedures will be welcomed by many organisations throughout the world who are required to prove that the validity of their analytical results can be established beyond reasonable doubt.
Download or read book Principles of Animal Nutrition written by Robin Moore and published by Scientific e-Resources. This book was released on 2018-04-14 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Animal Nutrition deals with classification and function of nutrients, deficiency symptoms, digestive processes, characterization of feedstuffs and formulation of diets for domestic animals. Animal nutrition entails the study of the composition and characteristics of the material consumed by the animal, the manner in which this material is metabolized (converted, utilized, and excreted) in the digestive tract and body cells of mono gastric animals (pigs, broilers, layers), ruminants (sheep, cattle, goats), and lower digestive tract fermenters (horses, ostriches). The nutrient requirements of different species animals for various production functions are also addressed. Nutrition is important for a variety of reasons. Animals need the proper nutrition for growth and maintenance, and to provide energy for work and vital functions. Maintenance is the nutrition required for an animal to maintain its current weight. Energy is the ability of the body to perform functions. Proper nutrition is also needed to maintain body temperature, produce milk, reproduce, and develop proper bone structures. Without proper nutrition, animals can develop health problems, which could result in treatment costs or even fatality. Good nutrition is essential for all of the systems of an animal to function and work together properly. This book contains the fundamental and basic information of subject and the selection of contents makes it an appropriate book for the students as well as for scholars.
Download or read book Introduction to Statistical Analysis of Laboratory Data written by Alfred Bartolucci and published by John Wiley & Sons. This book was released on 2015-12-02 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to Statistical Analysis of Laboratory Data presents a detailed discussion of important statistical concepts and methods of data presentation and analysis Provides detailed discussions on statistical applications including a comprehensive package of statistical tools that are specific to the laboratory experiment process Introduces terminology used in many applications such as the interpretation of assay design and validation as well as “fit for purpose” procedures including real world examples Includes a rigorous review of statistical quality control procedures in laboratory methodologies and influences on capabilities Presents methodologies used in the areas such as method comparison procedures, limit and bias detection, outlier analysis and detecting sources of variation Analysis of robustness and ruggedness including multivariate influences on response are introduced to account for controllable/uncontrollable laboratory conditions
Download or read book Validation of Alternative Methods for Toxicity Testing written by Chantra Eskes and published by Springer. This book was released on 2016-09-26 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 737 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Download or read book ORD Publications Announcement written by Center for Environmental Research Information (U.S.). and published by . This book was released on 1985 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Chemometrics in Chromatography written by Łukasz Komsta and published by CRC Press. This book was released on 2018-02-02 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chemometrics uses advanced mathematical and statistical algorithms to provide maximum chemical information by analyzing chemical data, and obtain knowledge of chemical systems. Chemometrics significantly extends the possibilities of chromatography and with the technological advances of the personal computer and continuous development of open-source software, many laboratories are interested in incorporating chemometrics into their chromatographic methods. This book is an up-to-date reference that presents the most important information about each area of chemometrics used in chromatography, demonstrating its effective use when applied to a chromatographic separation.
Download or read book Quality Assurance quality Control Guidelines for San Joaquin Valley Drainage Program Investigations written by H. L. Young and published by . This book was released on 1987 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Interlaboratory Studies and Certified Reference Materials for Environmental Analysis written by E.A. Maier and published by Elsevier. This book was released on 1999-12-17 with total page 587 pages. Available in PDF, EPUB and Kindle. Book excerpt: The participation in interlaboratory studies and the use of Certified Reference Materials (CRMs) are widely recognised tools for the verification of the accuracy of analytical measurements and they form an integral part of quality control systems used by many laboratories, e.g. in accreditation schemes. As a response to the need to improve the quality of environmental analysis, the European Commission has been active in the past fifteen years, through BCR activity (now renamed Standards, Measurements and Testing Programme) in the organisation of series of interlaboratory studies involving expert laboratories in various analytical fields (inorganic, trace organic and speciation analysis applied to a wide variety of environmental matrices). The BCR and its successor have the task of helping European laboratories to improve the quality of measurements in analytical sectors which are vital for the European Union (biomedical, agriculture, food, environment and industry); these are most often carried out in support of EC regulations, industrial needs, trade, monitoring activities (including environment, agriculture, health and safety) and, more generally, when technical difficulties hamper a good comparability of data among EC laboratories. The collaborative projects carried out so far have placed the BCR in the position of second world CRM producer (after NIST in the USA).Interlaboratory Studies and Certification of Reference Materials for Environmental Analysis gives an account of the importance of reference materials for the quality control of environmental analysis and describes in detail the procedures followed by BCR to prepare environmental reference materials, including aspects related to sampling, stabilization, homogenisation, homogeneity and stability testing, establishment of reference (or certified) values, and use of reference materials. Examples of environmental CRMs produced by BCR within the last 15 years are given, which represent more than 70 CRMs covering different types of materials (plants, biological materials, waters, sediments, soils and sludges, coals, ash and dust materials) certified for a range of chemical parameters (major and trace elements, chemical species, PAHs, PCBs, pesticides and dioxins).The final section of the book describes how to organise improvement schemes for the evaluation method and/or laboratory performance. Examples of interlaboratory studies (learning scheme, proficiency testing and intercomparison in support to prenormative research) are also given.
Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Download or read book Assessing Quality and Safety of Animal Feeds written by Samuel Jutzi and published by Food & Agriculture Org.. This book was released on 2004 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication provides information on the impact of animal feeds on food quality, food safety, and the environment, and thus improves the basis for managing such risks. The book brings together in printed form six reviews from the FAO electronic journal AGRIPPA (available online).
Download or read book Evaluation and Optimization of Laboratory Methods and Analytical Procedures written by A. Dijkstra and published by Elsevier. This book was released on 1978-01-01 with total page 659 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evaluation and Optimization of Laboratory Methods and Analytical Procedures
Download or read book Quantifying Uncertainty in Analytical Measurement written by Eurachem/CITAC Working Group and published by . This book was released on 2000-01-01 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guidelines for Quality Management in Soil and Plant Laboratories written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 1998 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Principles and Practices of Method Validation written by A Fajgelj and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a large number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.
