Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical [Hardcover]

Syed Imtiaz Haider (Author)

Book Description

ISBN-10: 1574443313 | ISBN-13: 978-1574443318 | Publication Date: December 27, 2001 | Edition: 1

A comprehensive when-and-how-to-do-it guide, this book and CD-ROM combination provides administrative solutions for achieving compliance with key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation. The text shows readers how to establish test functions and acceptance criteria in compliance with FDA perspectives. The CD-ROM contains 74 template validation standard operating procedures that users can edit and print, customizing the program to their needs. The book and CD work together to minimize the number of forms used and to ensure that the all the correct forms are used, thus avoiding the stress that usually accompanies an FDA audit.

Editorial Reviews

About the Author

Haider; Syed Imtiaz Gulf Pharmaceuticals Industries, United Arab Emirates,

Product Details

• Hardcover: 496 pages
• Publisher: CRC; 1 edition (December 27, 2001)
• Language: English
• ISBN-10: 1574443313
• ISBN-13: 978-1574443318
• Product Dimensions: 9.5 x 6.3 x 1.3 inches
• Shipping Weight: 2 pounds
• Average Customer Review: 1.0 out of 5 stars  See all reviews (1 customer review)
• Amazon Best Sellers Rank: #3,702,975 in Books (See Top 100 in Books)

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Customer Reviews

Most Helpful Customer Reviews

14 of 15 people found the following review helpful:

1.0 out of 5 stars Sad - this book could have used an Editor, April 2, 2007

By 

cousette copeland "codyhaha" (santa clara, california USA) - See all my reviews
(REAL NAME)   

Amazon Verified Purchase

This review is from: Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition (Hardcover)

First of all - no index.
Second - the CD has examples that are poorly and inconsistently formatted. To use them, you'd have to spend time formatting everything. They should have used fonts, styles, etc. that are used in standard documents.
Thirdly - the book is huge so you'd expect more information on what to put in a Purpose, a Scope, etc. You don't get that. Instead you get a bunch of examples that must have been pulled from one or two companies.
If you are a professional writer like me, you don't want to waste time. You want something in template format that you can easily adapt to your company's product.
If there had been a review of this - I never would have bought it. I'm sorry but this book could have used an Editor. It was so disappointing and I'm so happy that Amazon understood my feelings and accepted the return of this book.
For a potential writer - here is a market! There are startup or small biotech/biomed companies that are trying to meet FDA regulations on SOPs and other related documents. Write a book and provide a CD with decent templates and examples! Hey, maybe I should do that. Good luck. I haven't found any other book that would help either....