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Author :
Publisher :
ISBN 13 :
Total Pages : 34 pages
Book Rating : 4.62/5 ( download)
Download or read book Guideline for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1988 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guidelines for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1987 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 28 pages
Book Rating : 4.59/5 ( download)
Download or read book Guideline for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1987 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Food and Drug Administration. Division of Microbiology
Publisher :
ISBN 13 :
Total Pages : 180 pages
Book Rating : 4.21/5 ( download)
Download or read book Bacteriological Analytical Manual written by United States. Food and Drug Administration. Division of Microbiology and published by . This book was released on 1969 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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ISBN 13 :
Total Pages : 68 pages
Book Rating : 4.42/5 ( download)
Download or read book Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances written by and published by . This book was released on 1987 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
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ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.87/5 ( download)
Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Michael E. Swartz
Publisher : CRC Press
ISBN 13 : 142001448X
Total Pages : 218 pages
Book Rating : 4.88/5 ( download)
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.
Author : Michael E. Swartz
Publisher : CRC Press
ISBN 13 : 1482229773
Total Pages : 95 pages
Book Rating : 4.76/5 ( download)
Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2018-10-03 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
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ISBN 13 :
Total Pages : 1366 pages
Book Rating : 4.24/5 ( download)
Download or read book Federal Register written by and published by . This book was released on 1982-10-19 with total page 1366 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Christopher M. Riley
Publisher : Elsevier
ISBN 13 : 9780080530352
Total Pages : 349 pages
Book Rating : 4.54/5 ( download)
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 349 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.
