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How to sell validatable equipment to pharmaceutical manufacturers PDF

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How to Sell Validatable Equipment to Pharmaceutical Manufacturers Erik Kopp informa healthcare CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 1999 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20130325 International Standard Book Number-13: 978-1-4822-0792-7 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. While all reasonable efforts have been made to publish reliable data and information, neither the author[s] nor the publisher can accept any legal responsibility or liability for any errors or omissions that may be made. The publishers wish to make clear that any views or opinions expressed in this book by individual editors, authors or contributors are personal to them and do not necessarily reflect the views/opinions of the publishers. The information or guidance contained in this book is intended for use by medical, scientific or health-care professionals and is provided strictly as a supplement to the medical or other professional’s own judgement, their knowledge of the patient’s medical history, relevant manufacturer’s instructions and the appropriate best practice guidelines. Because of the rapid advances in medi- cal science, any information or advice on dosages, procedures or diagnoses should be independently verified. The reader is strongly urged to consult the drug companies’ printed instructions, and their websites, before administering any of the drugs recommended in this book. This book does not indicate whether a particular treatment is appropriate or suitable for a particular individual. Ultimately it is the sole responsibility of the medical professional to make his or her own professional judgements, so as to advise and treat patients appropriately. The authors and publishers have also attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, please access www.copyright.com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com DEDICATION With special thanks to the following individuals: My best friend, my wife, Carla, who believed that I could really do this. My little helper, my son, Devin, who showed me that to achieve anything worthwhile in life you have to keep working at it and working at it and working at it, until you get it just right. My friend and colleague Dan Meshnick, who took a chance on bringing me into this industry and taught me most of what I know about this stuff. iii CONTENTS INTRODUCTION x 1. The Basics: The Regulations in Plain Language 1 Pharmaceutical Terminology 1 How the Regulations Affect the Pharmaceutical Industry 18 Summary 20 Notes 20 2. A (Very) Simple Validation Example 21 Equipment Qualification 22 IQ/OQ/PQ 22 Documentation 25 Process Validation 26 Additional Validation Requirements 29 Summary 33 3. Why Is Validation So Confusing? 35 Why the GMPs Are Vague 35 The PDAs Role in Enforcing the GMPs 36 The Pharmaceutical Industry's Role in Interpreting the GMPs 37 Who Is Qualified to Perform Validation? 43 Summary 46 Notes 46 v vi How to Sell Validatable Equipment to Pharmaceutical Manufacturers 4. What to Be Aware of Before Working on a Job for the Pharmaceutical Industry 47 Things the Equipment Supplier Can Do More Easily than the Pharmaceutical Company 51 Things Either Group (the Equipment Suppliers or the Pharmaceutical Companies) Can Do 52 Things the Pharmaceutical Company Can Do More Easily Than the Equipment Supplier 53 Summary 55 Notes 55 5. Providing Validatable Equipment: The Role of the Equipment Supplier 57 How the Equipment Supplier Can Help with Equipment Qualification 58 Design and Construct Equipment According to GMP and Company Requirements 59 Provide Documentation to Support Equipment Qualification 60 How the Equipment Supplier Affects the Cost of Validatable Equipment 62 The Extent of the Equipment Supplier's Involvement 65 Summary 66 Note 66 6. Pharmaceutical Industry Requirements for Process Equipment Design and Construction 67 Contact Surfaces 70 Materials of Construction 72 Common Materials Used 73 Materials to Avoid 75 Design and Construction of Pharmaceutical Process Equipment 75 Cleaning and Sanitization Considerations 76 Methods of Attachment 79 Contour 80 Valves 81 Elimination of Dead Legs in Water Distribution Systems 82 Penetrations into the Equipment (Ports) 83 Filters 84 Instrumentation (Measuring Devices) 85 Computerized and Automated Systems 86 Security of Control Systems 86 Separation of Process and Utility Streams 86 Drainage 87 Special Considerations for Cleanroom Equipment 88 Exterior Surfaces 89 Summary 89 Notes 90 Contents vii 7. Validatable Computer Systems 91 Types of Computer Systems 96 Solid State Controllers 96 Programmable Logic Controllers 97 Personal Computers 98 Functions of Computers in the Pharmaceutical Industry 98 Scope of Validation Needed for Computer Systems 98 How Much Validation Needs to Be Done? 100 Level of Confidence in Computer Systems 100 Importance of Computer Systems Applications 102 Requirements for Completing Computer Systems Validation 102 General Computer Systems Validation Practices 103 Step 1: Define What the System Is Supposed to Do 105 Step 2: Describe How the System Will Accomplish What It Is Supposed to Do 107 Step 3: Select or Construct Appropriate Hardware That Will Satisfy the Requirements and Specifications Defined in Steps 1 and 2 109 Step 4: Develop Software That Will Satisfy the Requirements Defined in Steps 1 and 2 109 Step 5: Install the System 119 Step 6: Release the System to the Pharmaceutical Company and Let It Test It 122 Step 7: Provide Support As Needed to Keep the System Running Properly 122 Key Points 124 Validatable Hardware 127 Validatable Software 126 Categorization of Software 129 Customized Software 129 Widely Distributed Software 130 Configurable Software 130 Specialized Software 131 Validation Requirements for Suppliers of Computerized Equipment 133 Summary 136 Notes 136 8. Documentation: The Foundation of Good Manufacturing Practices 137 Rule #1 All Entries Must Be Made in Permanent Ink 138 Rule #2 Never Obliterate Data 138 Rule #3 All Documentation Must Be Signed 139 Rule #4 Original Records Are the Most Important 140 Rule #5 Use Templates and Forms 142 Rule #6 Leave No Missing Information 142 viii How to Sell Validatable Equipment to Pharmaceutical Manufacturers Rule #7 Reference Procedures and Standards Whenever Possible 143 Rule #8 Drawings Should Be an Accurate Representation of the Equipment Being Supplied to the Pharmaceutical Company 144 Rule #9 Provide All the Manuals with the Equipment 145 Rule #10 Provide All the Documentation in One Package 146 General Comments 147 Summary 147 Notes: 148 9. The Turnover Package 149 Elements of a Good Turnover Package: Contents 150 Elements of a Good Turnover Package—Purpose Behind the Information 152 Manuals 152 Parts Lists 153 Bill of Materials 154 Technical Specifications 154 Inspection Certificates 155 Passivation Records 156 Calibration Certificates 156 Mill Certificates 158 As-Built Drawings 159 Computer Systems Documentation 160 Test Records 162 Procedures 163 Summary 164 10. Providing Added Value Without a Lot of Extra Work 165 Step 1: Ask Customers Exactly What They Expect 165 Step 2: Be Up-Front about What You Know and What You Can Do 168 Step 3: Get All the Facts You Need to Give Customers What They Need 169 Step 4: Factor in Any Extra Work Required 170 Step 5: Have Written Procedures for Handling Quality-Related Jobs 170 Step 6: Keep Good Records 171 Step 7: Use Standard Forms Whenever Possible 172 Step 8: Keep the Drawings Current 172 Step 9: Maintain Copies of Current Manuals and Technical Information 173 Step 10: Follow Good Quality Practices for Design and Development of Computer Programs 173 Step 11: Let the Pharmaceutical Companies Come in and See What a Good Job You Are Doing 174 Contents ix Step 12: Follow Up on All the Details (Even If They Don't Seem to Be Important or Make Sense) 175 Step 13: Treat the Documentation with the Level of Importance It Deserves 175 Step 14: Communicate Throughout the Project 176 Step 15: If You Provide Services to the Pharmaceutical Industry, You Need to Follow Its Rules 176 Summary 177 11. Validation Hang-Ups: What to Watch Out for and How to Avoid Them 179 Validation Hang-Up #1 Not Recognizing the Need for Validation 180 Validation Hang-Up #2 Not Wanting to Confront Regulations 181 Validation Hang-Up #3 Raising Expectations beyond What Can Be Delivered 182 Validation Hang-Up #4 Not Providing All the Documentation in a Timely Manner 183 Validation Hang-Up #5 Not Providing Technical Follow-Up Support 183 Summary 184 12. Validation Services Performed by Equipment Suppliers 185 How to Validate Pharmaceutical Process Equipment: Step-by-Step Instructions for Preparing Validation Documents 187 Step 1: Write the Protocol 187 Step 2: Get the Protocol Approved by the Pharmaceutical Company 189 Step 3: Perform the Work According to the Protocol and Document the Results 189 Step 4: Prepare the Report 190 Step 5: Get the Report Approved by the Pharmaceutical Company 191 How to Validate Pharmaceutical Process Equipment: Step-by-Step Instructions for Conducting Equipment Qualification Studies 192 Conducting Installation Qualifications 193 Installation Qualification Documentation 197 Requirements for Operation Qualification 197 Functional Testing 198 Operational Testing 199 Eventful Testing 201 Documentation of Operation Qualification 202 Pointers for Conducting IQ and OQ 202 Summary 203 13. Conclusion 205 x How to Sell Validatable Equipment to Pharmaceutical Manufacturers Attachments 1. Current Good Manufacturing Practices (cGMPs) 209 2. Documentation Examples 245 3. Example Procedure (SOP) 257 4. Project Planning Questionnaire 261 5. Example Turnover Package 267 6. Example IQ Protocol 301 7. Example OQ Protocol 321 References 341 Index 343 INTRODUCTION If you are supplying or planning to supply manufacturing equipment to pharmaceutical companies, it is important to have a good understanding of what your customers need from you to meet government regulations. The pharmaceutical industry is strictly regulated by the Food and Drug Admin istration (FDA) to ensure the products they produce are safe and effective. As part of these regulations, the processes and equipment used to produce drug products must be validated before they can be produced for human use. Validation is an essential step in assuring the quality of drug products. This means the equipment must be validated before it is used to produce any salable products. If it cannot be validated, it cannot be used. What is validation? Who does validation? How is validation accom plished? How much of this does an equipment supplier need to know? Don't pharmaceutical companies handle validation? These are the questions that will be covered in the chapters that follow. Validation has been my occupation for almost 10 years. Since I started in validation, I've held positions at pharmaceutical, medical device, and con sumer products/over-the-counter companies. I've been involved in many equipment purchase and start-up projects. Some went smoothly and some were troublesome. A lot of the troubles were the result of validation issues. Many times, validation issues were not considered as part of the pro ject from the start. As a result, after the equipment was delivered and installed, it couldn't be used because the validation was inadequate. In these situations, a lot of time and money was spent trying to get everything in order. At this point, validation can seem like a lot of extra work and expense. I've been in heated discussions with equipment suppliers in which the following statements were made, "Why do you need this? The equip ment works doesn't it?" and "This is just extra paperwork to keep you busy!" and "Isn't that your job—to validate this?" xi

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