An Easy to Understand Guide to Cleaning Validation

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  • An Easy to Understand GuideAn Easy to Understand Guide

    Cleaning ValidationCleaning Validation

    Connecting the Life Sciences

    askaboutValidationThe Validation Specialists

  • An Easy to Understand Guide

    Cleaning Validation

    Published by Premier Validation

    An Easy to Understand Guide | Cleaning Validation

  • Cleaning Validation

    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 in 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

    ISBN 978-1-908084-03-3

    An Easy to Understand Guide | Cleaning Validation

  • So whats this book all about?

    Hey there,

    This book has drawn on years of the author's experience in the field of

    cleaning validation within regulated environments, specifically the

    Biotechnology and Pharmaceutical sector. This book has been published as

    an aid to anyone who is interested in learning more about cleaning

    validation within a regulated environment.

    If you would like to expand your knowledge of cleaning validation, but

    find it difficult to get involved on cleaning validation projects, this book is the

    perfect starting point. Written in a clear concise manner An Easy to

    Understand Guide to Cleaning Validation is just that. If you find white papers

    and pharmaceutical books too daunting, join the club you're not alone.

    Unlike those offering's our easy to read book will bring you up to speed with

    the world of cleaning validation very quickly, explaining the basics of what is

    involved.

    If you've struggled with such terms as TOC, HPLC, Therapeutic Dose,

    MACO, NOEL, Lethal Dose and Dirty Hold Times then this book is for you. The

    purpose of this book is to pull all of that together, and make a cleaning

    validation book that provides an easy launchpad to allow users of this book

    to search for more detailed information as and when it is required.

    Enjoy!

    An Easy to Understand Guide | Cleaning Validation

  • The brains behind the operation!

    Program Director: Graham O'Keeffe

    Content Author: Trefor Jones

    Technical Editor: Dr Shahid Ali Syed

    Editor: Anne-Marie Smith

    Printing History: Edition: July 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.

    Published by Premier Validation Ltd

    Web: www.premiervalidation.com

    Forum: www.askaboutvalidation.com

    Email: query@premiervalidation.com

    ISBN 978-1-908084-03-3

    Print and bound in the United Kingdom

    The Validation Specialists

    An Easy to Understand Guide | Cleaning Validation

  • An Easy to Understand Guide | Cleaning Validation

    Table of Contents

    The Starting Line 1

    Why Should I Read this Book? 2

    Learning Objectives 3

    Why Clean? 4

    What is Cleaning Validation? 6

    Why Perform Cleaning Validation? 9

    Rules And Guidelines 10

    Regulatory Requirements 11

    Guidelines 13

    The Cleaning Validation Process 15

    The Scope of Cleaning Validation 17

    The Cleaning Validation Sequence 19

    Pre-requisites 20

    Cleaning Validation Strategy, Plan & Policy 21

    Sampling 28

    Recovery Studies 34

    Analytical Method Selection and Development 36

    Analytical Method Validation 38

  • An Easy to Understand Guide | Cleaning Validation

    Acceptance Criteria 39

    Cleaning Method Development 47

    Validation Master Plan 50

    Cleaning Validation Plan 52

    Cleaning Process Standard Operating Procedures (SOP) 55

    Cleaning Validation Protocols 57

    Protocol Execution 60

    Deviations 62

    Clean and Dirty Hold Times 63

    Validation Report 67

    Post Validation Monitoring 69

    Maintaining the Validated Status 70

    Retrospective Cleaning Validation 72

    Glossary 75

    Cleaning Validation Quiz 78

    Answers 80

    Score 82