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Author:
Publisher:
ISBN:
Category : Mines and mineral resources
Languages : en
Pages : 562
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Author: Nabil A. Bibawy
Publisher:
ISBN:
Category : Helium
Languages : en
Pages : 24
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Author:
Publisher:
ISBN:
Category : Mines and mineral resources
Languages : en
Pages : 426
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Book Description
Author: United States. Bureau of Mines
Publisher:
ISBN:
Category : Fuel
Languages : en
Pages : 182
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Author:
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ISBN:
Category : Geology
Languages : en
Pages : 906
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Book Description
Author: Donna L. Anderson
Publisher:
ISBN:
Category : Coal-mining machinery
Languages : en
Pages : 558
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Book Description
Author: Chung Chow Chan
Publisher: John Wiley & Sons
ISBN: 1118060318
Category : Science
Languages : en
Pages : 363
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Book Description
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.
Author:
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ISBN:
Category : Administrative law
Languages : en
Pages : 1076
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Book Description
Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
Author: United States. Bureau of Mines
Publisher:
ISBN:
Category : Mineral industries
Languages : en
Pages : 654
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Author: Office of The Federal Register
Publisher: IntraWEB, LLC and Claitor's Law Publishing
ISBN: 1640243984
Category : Law
Languages : en
Pages : 872
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Book Description
(Volume 9) Part 60 (Appendices)
Author: Office of The Federal Register
Publisher: IntraWEB, LLC and Claitor's Law Publishing
ISBN: 1640241531
Category : Law
Languages : en
Pages : 870
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Book Description
