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

~ Syed Imtiaz Haider (Author) "This Validation Master Plan (VMP) specifies and coordinates all qualification/validation activities to ensure the production of pharmaceutical products according to accepted international standards..." (more)
Key Phrases: appropriate supervisory control, controls verification testing, accordance with design specifications, Perform Installation Qualification, Location Equipment Name, Air Change Air Flow (more...)

Editorial Reviews

Product Description

The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you 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 allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. 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: 208 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.com Sales Rank: #1,369,751 in Books (See Bestsellers in Books)

Customer Reviews

Most Helpful Customer Reviews

6 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 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.

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

By A Customer

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.

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

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.