Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance [Hardcover]

Syed Imtiaz Haider (Author)

Book Description

ISBN-10: 1574443305 | ISBN-13: 978-1574443301 | Publication Date: December 27, 2001

This book provides the tools to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD provides a template that can be customized to incorporate additional regulatory requirements specific to individual companies worldwide. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

Product Details

• Hardcover: 176 pages
• Publisher: Informa Healthcare (December 27, 2001)
• Language: English
• ISBN-10: 1574443305
• ISBN-13: 978-1574443301
• Product Dimensions: 8.9 x 6.1 x 0.7 inches
• Shipping Weight: 14.4 ounces (View shipping rates and policies)
• Average Customer Review: 2.3 out of 5 stars  See all reviews (3 customer reviews)
• Amazon Best Sellers Rank: #1,647,868 in Books (See Top 100 in Books)

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Customer Reviews

Most Helpful Customer Reviews

6 of 7 people found the following review helpful:

1.0 out of 5 stars No actual content, February 13, 2004

By A Customer

This review is from: Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance (Hardcover)

I'm sorry to report that this book merely presents an outline of steps to take, along with a collection of document templates, neither of which contain any actual "content". In other words, it tells you "what", but not "how". If you're looking for insight and real-world examples, look elsewhere. I couldn't justify a bunch of blank forms and outlines for such a cover-price. I sent mine back and Amazon graciously refunded my money.

5 of 6 people found the following review helpful:

1.0 out of 5 stars BIG WASTE of MONIES and TIME, November 9, 2006

By 

efila "Val Exp" (Minnesota) - See all my reviews

This review is from: Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance (Hardcover)

This book may be just as the Author intended, an outline of how to set things in motion. AND, that is all that this is. Don't fool around with this one... you'd be better off going to the FDA site for their guidelines.

The CD is a jokingly filled example of templates that waste your time and you have to put more energy into them to configure for your uses.

ALSO, there really is NO MASTER VALIDATION PLAN within this. It's a poor example of going about things. It may seem clear, but there is no flow to it whatsoever and it is confusing.

I've been in this field of Validation and MVP and medical for yrars... this is a pure MESS. Soon, I might write a real book.

2 of 4 people found the following review helpful:

5.0 out of 5 stars Master Validation Plan, September 12, 2003

By 

shivohm "kiruna" (Buffalo Grove, IL United States) - See all my reviews

Amazon Verified Purchase

This review is from: Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance (Hardcover)

I have reviewed this excellent book. This book guides you through all process required for validation from FDA. In new edition, the author should give more details and technical guidance for control systems and software validation. Also to help in 21 CFR 11 approval. CD-ROM with the book is a help to cut down all the time wasted in formatting information and make templtes for crtical forms. Congratulations for writing this exceelent book.