How to be an Effective GMP Auditor The Validation Specialists askaboutValidation Connecting the Life Sciences How to be an Effective GMP Auditor Published by Premier Validation How to be an Effective GMP Auditor How to be an Effective GMP Auditor First Edition © Copyright 2013 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. How to be an Effective GMP Auditor So what’s this book all about? Hey there, If you've decided to invest some time in reading this book, I am making the assumption that you are pretty tired of wading through scientific white papers and 500 page books designed to confuse the hell out of everyone! This quick and easy guide describes how to become an efficient GMP Auditor and identifies the critical competencies needed to be a conscientious auditor. This book has been written for: ü New auditors or individuals wanting to become GMP auditors. ü Professionals who are responsible for conducting internal or vendor GMP audits. ü Suppliers and others who are audited by different professionals such as quality assurance and quality control specialists, validation engineers, manufacturing specialists, regulatory specialists and management. It will also determine which regulations and standards are applicable together with a lot more useful information required for any GMP regulatory audit. Enjoy! How to be an Effective GMP Auditor The brains behind the operation! Program Director: Graham O'Keeffe Content Author: Joginder Mittal Technical Editor: Alan Smith, Graham O'Keeffe, Peter Jacobs, Irene Kaas. Editor: Anne-Marie Smith Printing History: Edition: 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: [email protected] ISBN 978-1-908084-11-8 Print and bound in the United Kingdom How to be an Effective GMP Auditor Table of Contents The Starting Line 1 Why Should I Read This Book? 2 Learning Objectives 3 Terms Explained 4 Introduction to Auditing 7 What is an Audit? 8 What is a GMP Audit? 8 Why GMP Audit? 10 Types of GMP Audit 12 Internal Audit (Self Inspection) 13 Regulatory Audit 15 Who Conducts GMP Audits? 16 Key Principles of GMP Audit 17 Benefits of GMP Audit 19 GMP Audit Process 20 Phase I: Preparation and Planning of the GMP Audit 23 Determine the Basis for the Audit 24 Determine the Feasibility of the Audit 27 Review Documents 28 Prepare the Audit Plan 29 Communicate Audit Plan 30 How to be an Effective GMP Auditor Prepare Work Documents 30 Phase 2: Performing the Quality Audit 31 The Opening Meeting 31 The Site / Area Tour 33 Collect Information 35 Beginning the “Conference Room” Audit 38 Auditing Techniques 39 Generate Audit Findings 42 The Daily Wrap-up (For multiple day audits) 42 Classify Audit Observations 43 The Close-Out Meeting 46 Phase 3: Preparation, Approval and Distribution of the Audit Report 47 Preparation of the audit report 47 Approve and Distribute the Audit Report 49 Conduct Audit Follow-up 49 Phase 4: Audit Closure 50 System Based Approach 51 Quality Assurance System 53 Validation / Qualification System 54 Material System 54 Premises and Equipment System 55 Production System 56 How to be an Effective GMP Auditor Packaging and Labeling System 57 Laboratory Control System 57 Research and Development System (R & D) 58 Engineering and Maintenance System 59 Utilities System 60 Warehousing System 60 GMP Auditor 61 Professional Experience 62 Knowledge and Skills 63 Personal Suitability 65 Difficult Situations 66 Annexure 67 Annexure 1– Examples of Audit Findings 68 Annexure 2– Know your GMP Standards– The Regulatory Bodies 77 References 81 Exercise 83 How to be an Effective GMP Auditor