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

by Syed Imtiaz Haider (Author) "To describe the definition, types, and benefits of validation..." (more)
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Editorial Reviews

Product Description
One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United States. The lack of well defined validation standard operating procedures may result in adverse FDA findings, recalls, and heavy financial losses. Key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation do not describe exactly how to develop a master validation plan, how to achieve compliance, or the standard operating procedures and documentation required. This text provides the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry. The text and CD are designed to minimize workload and optimize time, money, and resources. A comprehensive when-and-how-to-do-it guide, Validation Standard Operating Procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States. The CD-ROM contains 74 template validation standard operating procedures that can be tailored to meet the regulatory compliance requirements of any pharmaceutical, diagnostic, medical device, medical equipment, and biotech product. You can edit, print, and customize these procedures to fit your needs. The book and CD work together to minimize the number of documents used and to ensure their accuracy. All critical elements and requirements of validation are covered, so you can easily implement them and avoid the stress that usually accompanies an FDA audit.Features"Provides all the information that managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines"Includes step-by-step directions for translating GMP requirements into action, based on your company's Master Validation Plan and execution protocols "Describes how to establish test functions and prevent defects in order to produce products that are fit for use"Serves as an ideal companion to Haider's Pharmaceutical Master Validation Plan

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.com Sales Rank: #1,743,187 in Books (See Bestsellers in Books)

Customer Reviews

Most Helpful Customer Reviews

12 of 12 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)

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....