Basic Method Validation

Author : James O. Westgard
Publisher : AACC Press
ISBN 13 : 9781886958197
Total Pages : 292 pages
Book Rating : 4.9X/5 ( download)

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Download or read book Basic Method Validation written by James O. Westgard and published by AACC Press. This book was released on 2003-01-01 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.

Author : James O. Westgard
Publisher :
ISBN 13 :
Total Pages : 268 pages
Book Rating : 4.46/5 ( download)

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Download or read book Basic Method Validation written by James O. Westgard and published by . This book was released on 1999 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : James O. Westgard
Publisher :
ISBN 13 : 9781886958333
Total Pages : 308 pages
Book Rating : 4.35/5 ( download)

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Download or read book Basic Method Validation and Verification, 4th Edition written by James O. Westgard and published by . This book was released on 2020-08 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Christopher M. Riley
Publisher : Elsevier
ISBN 13 : 0080530354
Total Pages : 363 pages
Book Rating : 4.52/5 ( download)

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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.

Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.70/5 ( download)

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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.

Author : James O. Westgard
Publisher :
ISBN 13 : 9781886958302
Total Pages : 290 pages
Book Rating : 4.00/5 ( download)

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Download or read book Basic QC Practices, 4th Edition written by James O. Westgard and published by . This book was released on 2016-07 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : James O. Westgard
Publisher : Westgard Quality Corporation
ISBN 13 : 9781886958258
Total Pages : 320 pages
Book Rating : 4.54/5 ( download)

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Download or read book Basic Method Validation written by James O. Westgard and published by Westgard Quality Corporation. This book was released on 2008-01-01 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Wesley M. Johnson
Publisher : FriesenPress
ISBN 13 : 1460210271
Total Pages : 81 pages
Book Rating : 4.77/5 ( download)

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Download or read book Application of Iso/Iec 17025 Technical Requirements in Industrial Laboratories written by Wesley M. Johnson and published by FriesenPress. This book was released on 2013-03 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book introduces the new concepts of target measurement uncertainty and decision rules and explains how to use them to demonstrate a method is fit-for-purpose. As well, they can be used to set the acceptance criteria for a method validation clearly and quantitatively. Examples are given that illustrate the concepts so that the reader can easily apply decision rules and target measurement uncertainty to their methods. The book covers all aspects of method validation from stating the purpose of the method using a Decision Rule, calculating the target measurement uncertainty, deciding the required parameters that need to be included in the method validation, estimating the measurement uncertainty, and setting the acceptance criteria. With this approach the reader will fully understand the method, what its critical control points are and what to control and monitor during routine use. This approach fits in well with the lifecycle approach to analytical methods. The book covers the basics and advanced aspects of method validation so that it is useful for people new to method validation and those with experience. The book is applicable for laboratories in many industries, from mining to pharmaceutical manufacturing to food analysis....

Author : James O. Westgard
Publisher :
ISBN 13 : 9781886958272
Total Pages : 296 pages
Book Rating : 4.70/5 ( download)

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Download or read book Six Sigma Risk Analysis written by James O. Westgard and published by . This book was released on 2011 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk Analysis is coming to medical laboratories. But for too many labs, Risk Analysis is a buzzword without meaning, an approach without defined technique. At worst, it threatens to appear like science while being implemented like guesswork. In this book, Dr. Westgard surveys the ISO standards, as well as published CLSI guidelines, and the long-established Joint Commission methodology for Proactive Risk Reduction. After providing an overview of the general Risk Analysis approach, Dr. Westgard explains how to adapt the principles for the medical laboratory, with performance-based tools and practical implementation tips: * Process maps, flowcharts and fishbone diagrams * Risk Acceptability matrices * Assessment of hazards through Failure Mode Effects Analysis (FMEA) * Fault Tree Analysis (FTA) and Failure Reporting, Analysis and Corrective Actions System (FRACAS) * Six Sigma metric integration into Risk Analysis Using Six Sigma metrics, Dr. Westgard shows how Risk Analysis can be converted from qualitative and ephemeral to something more quantitative and concrete. When performance data informs Risk Analysis, the decisions become more relevant to medical laboratories and the patients they serve. Don't settle for arbitrary guesswork in your Risk Analysis. Combine the power of Six Sigma and Risk Analysis tools.

Author : Mark Stauffer
Publisher : BoD – Books on Demand
ISBN 13 : 1789230845
Total Pages : 176 pages
Book Rating : 4.40/5 ( download)

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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.