An Easy to Understand Guide

Risk Based Equipment Qualification

The Validation Specialists

askaboutValidation
Connecting the Life Sciences

An Easy to Understand Guide

Risk Based Equipment Qualification

Published by Premier Validation

An Easy to Understand Guide | Risk Based Equipment Qualification

Equipment Qualification First Edition Copyright 2011 Premier Validation All rights reserved. No part of the content or the design of this book maybe reproduced or transmitted in any form or by any means without the express written permission of Premier Validation.

The advice and guidelines in this book are based on the experience of the authors, after more than a decade within the Life Science industry, and as such is either a direct reflection of the predicate rules (the legislation governing the industry) or are best practices used within the industry.

The author takes no responsibility for how this advice is implemented.

Visit Premier Validation on the web at www.premiervalidation.com or visit our forum at www.askaboutvalidation.com.

An Easy to Understand Guide | Risk Based Equipment Qualification

So whats this book all about?

Hey there, If you're reading this, I'm going to assume you're here to learn about how to perform risk based Equipment Qualification activities and how they are applied within any compliance based environment. Equipment Qualification activities are the foundations upon which process validation is built and these activities play a critical role in delivering operationally effective, safe and efficient facilities, utilities and equipment. So it is important to ensure that a comprehensive and systematic approach is undertaken during the qualification process. What & How to qualify? This is still a big & confusing question for the industry professionals!! This Book explains how to find out the level of Equipment Qualification required, fulfilling the regulatory requirements along with eliminating the duplication & cumbersome documentation efforts. So, if you want to learn about the systematic way of risk based Equipment Qualification approach, this is the book for you. Don't worry this isn't the usual boring scientific book or white paper that you've seen a thousand times, our books are an easy read and get straight to the point.

Enjoy!

An Easy to Understand Guide | Risk Based Equipment Qualification

The brains behind the operation!

Program Director: Graham O'Keeffe Content Author: Joginder Mittal Technical Editor: Dr Shahid Ali, Graham O'Keeffe, Peter Thompson, Mo Acton. Editor: Anne-Marie Smith Printing History: Edition: Oct 2011 Cover and Graphic Design: Those Concepts

Notes of Rights
All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without the prior written permission of the copyright holder, except in the case of brief quotations embedded in critical articles or reviews.

Notes of Liability
The author and publisher have made every effort to ensure the accuracy of the information herein. However, the information contained in this book is sold without warranty, either express or implied. Neither the authors and Premier Validation Ltd, nor its dealers or distributors will be held liable for any damages to be caused either directly or indirectly by the instructions contained in this book.

The Validation Specialists

Published by Premier Validation Ltd Web: www.premiervalidation.com Forum: www.askaboutvalidation.com Email: query@premiervalidation.com ISBN 978-1-908084-08-8 Print and bound in the United Kingdom

An Easy to Understand Guide | Risk Based Equipment Qualification

Table of Contents
The Starting Line Why Should I Read This Book? Learning Objectives Terms Explained Qualification versus Validation What are the Benefits of Equipment Qualification? 1 2 4 5 6 7

Equipment Qualification Process Qualification Planning Risk Based Impact Assessment - Qualification Need Assessment

9 10

13

Qualification Phases User Requirement Specification (URS) Risk Assessment What is FAT/SAT? Equipment Design Qualification (DQ) Equipment Installation qualification (IQ) Equipment Operational Qualification (OQ) Equipment Performance Qualification (PQ) Requalification Change Control REFERENCES

23 24 25 44 45 48 51 55 59 61 65

An Easy to Understand Guide | Risk Based Equipment Qualification