Since 1994, the German GMA-NAMUR, German APV, ISPE-Baseline, OECD, UK GAMP Forum, UK IQA-PQG, US DIA, ISPE, and PDA initiatives have supplemented the regulations governing the validation of automated systems with high-level guidelines. The result has been a broadly accepted industry framework for validating automation systems. This book deals directly with project problems and their resolutions based upon the experience of established industry practitioners. It introduces the principles of good practice and why validation is needed, presents a comprehensive selection of case studies provided by industry experts, and concludes with the Ten Commandments for Validating Automation.
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This review is from: Validating Automated Manufacturing and Laboratory Applications: Putting Principles into Practice (Hardcover)
I found this book really practical. FDA requirements can be ambiguous to say the least when it comes to making them work in practice. This book laid out a clear methodology that was easy to apply. The numerous case studies helped too as I could see how validation could be tailored to different situations and systems.
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Inside This Book
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First Sentence:
A very common situation is pharmacists using apparatus that they do not fully understand, and engineers building apparatus that might not satisfy the demands to be placed on it. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
eccentric tablet press, computerized flowmeter, moist agglomeration process, instrumented tablet press, bioadhesion tests, rotary tablet machines, measuring bioadhesion, predelivery testing, lower punch force, tablet machine instrumentation, die wall pressure, core bed, process computer system, granulating liquid, tablet compaction, bioadhesive system, maximum compression force, rotary tablet press, piezoelectric load cells, tablet compression, tableting process, film coating process, punch displacement, adhesion work, bioadhesive properties Key Phrases - Capitalized Phrases (CAPs): (learn more)
Drug Dev, New York, Powder Technol, Acta Pharm, Ridgway Watt, User Requirements Specification, Factory Acceptance Testing, National Instruments, Pharmaceutical Instrumentation, Data Translation, John Wiley, The Netherlands, European Pharmacopoeia, Keithley Metrabyte, Quality Plan, Academic Press, Plenum Press, Wiederkehr-von Vincenz, Acta Hely, Boca Raton, Bulk Solids Handling, Controlled Drug Delivery, Courtesy of Zymark, Hosokawa Micron, Hottinger Baldwin Messtechnik New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
A very common situation is pharmacists using apparatus that they do not fully understand, and engineers building apparatus that might not satisfy the demands to be placed on it. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
eccentric tablet press, computerized flowmeter, moist agglomeration process, instrumented tablet press, bioadhesion tests, rotary tablet machines, measuring bioadhesion, predelivery testing, lower punch force, tablet machine instrumentation, die wall pressure, core bed, process computer system, granulating liquid, tablet compaction, bioadhesive system, maximum compression force, rotary tablet press, piezoelectric load cells, tablet compression, tableting process, film coating process, punch displacement, adhesion work, bioadhesive properties Key Phrases - Capitalized Phrases (CAPs): (learn more)
Drug Dev, New York, Powder Technol, Acta Pharm, Ridgway Watt, User Requirements Specification, Factory Acceptance Testing, National Instruments, Pharmaceutical Instrumentation, Data Translation, John Wiley, The Netherlands, European Pharmacopoeia, Keithley Metrabyte, Quality Plan, Academic Press, Plenum Press, Wiederkehr-von Vincenz, Acta Hely, Boca Raton, Bulk Solids Handling, Controlled Drug Delivery, Courtesy of Zymark, Hosokawa Micron, Hottinger Baldwin Messtechnik New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 64
books:
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17
books
cite this book:
See all 17 books citing this book
- The Theory and Practice of Industrial Pharmacy by Leon Lachman on 5 pages
- Review of Progress in Quantitative Nondestructive Evaluation: Volume 24A, Volume 24B (AIP Conference Proceedings / Review of Progress in Quantitative Nondestructive Evaluation) (v. 24a) by Donald O. Thompson on page 292, and page 293
- Hydrogels In Medicine by Peppas on page 337, and page 339
- Pharmaceutical Powder Compaction Technology (Drugs and the Pharmaceutical Sciences) by Goran Alderborn on page 220, and page 234
- Bioadhesive Drug Delivery Systems by Vincent M. Lenaerts on page 338, and page 339
See all 64 books this book cites
- The GCP Harmonization Handbook by Donald E. Maynard in Back Matter
- Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance by Syed Imtiaz Haider in Index
- Audit by Mail: Time and Cost Effective GMP Audit Tool by John Lyall in Back Matter
- How to Develop and Manage Qualification Protocols for FDA Compliance by Phil Cloud in Back Matter
- International Clinical Trials: A Guidebook and Compendium of National Drug Laws, Two-Volume Set by Dominique Brunier in Back Matter
See all 17 books citing this book
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