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Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook download epub

by Phil Cloud


Epub Book: 1520 kb. | Fb2 Book: 1129 kb.

The equipment qualification methods de­ scribed in this book are designed to support the current Good Manufacturing Prac­ tices (cGMP) in a solid dosage form manufacturing environment. The mortar and pestle have been replaced by automated pharmaceutical processing equipment.

The equipment qualification methods de­ scribed in this book are designed to support the current Good Manufacturing Prac­ tices (cGMP) in a solid dosage form manufacturing environment.

Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to. .

Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols.

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Pharmaceutical Equipment Validation : The Ultimate Qualification Guidebook. By (author) Phil Cloud. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols.

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The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the .

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.

Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA .

Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance. Syed Imtiaz Haider more). Biotechnology: Quality Assurance and Validation.

Pharmaceutical Equipment Validation shows how to prepare, test, and complete equipment qualification protocols. It also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. Pharmaceutical Equipment Validation also includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols

While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.

Comments: (3)

SlingFire
Actual and concrete, if qualification is the target this book has the right way to think to do it. Fortunately right on time thanks to Amazon.com
Beazezius
This book had some good things of what a person may look into and for when starting to Validate Pharmaceutical Equipment. There are so many example references to actual equipment that one could almost hear them running in their processes. It did not contain everything, but it sure did open one's eyes as to what to be aware of.

I did use this book in one instance for a non-pharmaceutical validation and its format helped me through it to a successful conclusion.

Overall, I was well pleased with this selection of mine. It's a great source for variety... makes you think a bit. This was good.
blac wolf
Pharmaceutical Equipment Validation by Cloud is a good basic text and lowest price from Amazon.
Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook download epub
Medicine & Health Sciences
Author: Phil Cloud
ISBN: 1574910795
Category: Other
Subcategory: Medicine & Health Sciences
Language: English
Publisher: CRC Press; 1 edition (August 31, 1998)
Pages: 456 pages