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FOOD & DRINK – GOOD MANUFACTURING PRACTICE A GUIDE TO ITS RESPONSIBLE MANAGEMENT FOOD & DRINK – GOOD MANUFACTURING PRACTICE A GUIDE TO ITS RESPONSIBLE MANAGEMENT Institute of Food Science and Technology (UK) 5 Cambridge Court 210 Shepherd’s Bush Road London W6 7NJ A John Wiley & Sons, Ltd., Publication This edition fi rst published 2013 © 2013 by John Wiley & Sons, Ltd. First through fi fth edition © The Institute of Food Science & Technology Trust Fund 1978, 1989, 1991, 1998, 2006 Wiley-Blackwell is an imprint of John Wiley & Sons, formed by the merger of Wiley’s global Scientifi c, Technical and Medical business with Blackwell Publishing. Registered offi ce: John Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK Editorial offi ces: 9600 Garsington Road, Oxford, OX4 2DQ, UK The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK 2121 State Avenue, Ames, Iowa 50014-8300, USA For details of our global editorial offi ces, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/ wiley-blackwell. The right of the author to be identifi ed as the author of this work has been asserted in accordance with the UK Copyright, Designs and Patents Act 1988. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher. Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought. Library of Congress Cataloging-in-Publication Data is available. 9781118318201 A catalogue record for this book is available from the British Library. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books. Cover design: www.hisandhersdesign.co.uk Set in 9/10.5 pt Times New Roman PS by Toppan Best-set Premedia Limited 1 2013 This guide is of an advisory nature. It has been compiled by the Institute of Food Science & Technology in consultation with other interested bodies. It has no statutory force, and nothing in it should be construed as absolving anyone from complying with legal requirements. All possible care has been taken in its preparation, and it is provided for general guidance without liability on the part of the Institute in respect of its application and use. Foreword Good manufacturing processes facilitate improvements in the industry, offering increased protection to consumers and businesses alike. Over the last few years, the EC legislation has been consolidated and simplifi ed, and now sets out, more clearly, the duty of food business owners to produce food safely. Furthermore, there is growing recognition that underpinning food manufacturing with robust quality assurance procedures can be benefi cial within a wider business context and simultaneously improve good practice. I am confi dent that this will lead to even more effi cient practice and better food safety across the sector. Greater confi dence in the entire manufacturing process will mean we can have more confi dence in the end product. I am pleased that this latest edition focuses on the need for the industry and senior management to take a more active role in the design, implementation, resourcing and promotion of appropriate and secure food safety processes. Lord Jeff Rooker Chair Food Standards Agency v CONTENTS Acknowledgements ix Prefaces ix Decision Makers’ Summary xiii Part I General Guidance Chapter 1 Introduction 1 2 Quality Management System 7 3 Hazard Analysis Critical Control Point (HACCP) 13 4 Food Allergens 23 5 Foreign Body Controls 31 6 Manufacturing Activities 39 7 Management Review and Internal Audit 49 8 Product and Process Development and Validation 53 9 Documentation 57 10 Product Identifi cation and Traceability 65 11 Personnel and Training 69 12 Premises and Equipment 85 13 Water Supply 101 14 Cleaning and Sanitation 105 15 Infestation Control 113 16 Purchasing 119 17 Packaging Materials 125 18 Internal Storage 129 19 Crisis Management, Complaints and Product Recall 133 20 Corrective Action 139 21 Reworking Product 143 22 Waste Management 147 23 Warehousing, Transport and Distribution 149 24 Contract Manufacture 155 25 Calibration 157 26 Product Control, Testing and Inspection 161 27 Labelling 165 28 Electronic Data Processing and Control Systems 169 29 Good Control Laboratory Practice and Use of Outside Laboratory Services 173 30 Environmental Issues 181 31 Health and Safety Issues 185 Part II Supplementary Guidance on Some Specifi c Production Categories Chapter 32 Heat-Preserved Foods 189 33 Chilled Foods 197 34 Frozen Foods 207 vii 35 Dry Products and Materials 213 36 Compositionally Preserved Foods 217 37 Foods Critically Dependent on Specifi c Ingredients 219 38 Irradiated Foods 221 39 Novel Foods and Processes 227 40 Foods for Catering and Vending Operations 231 41 The Use of Food Additives and Processing Aids 233 42 Responsibilities of Importers 237 43 Export 239 Part III Mechanisms for Review of This Guide Appendix I Defi nition of Some Terms Used in This Guide 243 Appendix II Abbreviations Used in the Guide 251 Appendix III Legislation and Guidance 255 Appendix IV Additional References 257 Appendix V List of Organisations and Individuals from Whom Help, Information or Comment Has Been Received 261 viii Acknowledgements A list of many of the organisations and individuals from whom help, information or comment has been received for this and previous editions is presented as Appendix V. This is inevitably incomplete and cannot include acknowledgement of numerous verbal comments received. However, I welcome the opportunity to thank all who participated and particularly the members, both past and present, of the GMP Working Groups. Especially, I would thank Professor J.R. Blanchfield, who as Editor and Convener of the GMP Working Group, 4th edition, has made an enormous contribution to the development of the 5th and 6th editions of this Guide. As with the previous editions, the preparation of this 6th edition has been an enjoyable and enlight- ening experience. Louise Manning Editor, 6th Edition Preface to the Sixth Edition The 6th edition has built on previous editions and has focused on the need for every food manufac- turing business to have established and implemented a food safety management system ( FSMS ) appropriate to the products being manufactured, supported and underpinned by the principles of good manufacturing practice ( GMP ). The adoption of all reasonable precautions relates not only to the measures that have been established in the design of the FSMS and associated quality manage- ment system ( QMS ), but also that these measures are fully implemented and are effective. There is a requirement therefore to introduce mechanisms for FSMS and QMS validation, and then re - validation as necessary, and for protocols to be established, identifying the measures for monitor- ing and verifi cation activities. Without these fully functioning and integrated dynamics being in place, due diligence cannot be actively demonstrated. Louise Manning ix PPrreeffaaccee ttoo tthhee FFiifftthh EEddiittiioonn TThhee 55tthh eeddiittiioonn hhaass bbeeeenn ddeevveellooppeedd ttoo mmeeeett tthhee vvaarriioouuss cchhaannggeess iinn ssttaakkeehhoollddeerr rreeqquuiirreemmeennttss ooff tthhee UUKK FFoooodd IInndduussttrryy ssiinnccee 11999988.. 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SSuussttaaiinnaabbllee ffoooodd bbuussiinneesssseess nneeeedd ttoo aaddddrreessss tthheessee iissssuueess ttoo pprroodduuccee ssaaffee,, wwhhoolleessoommee ffoooodd ooff aa ccoonnssiisstteenntt qquuaalliittyy tthhaatt mmeeeettss ccuussttoommeerr eexxppeeccttaattiioonnss.. LL.. MMaannnniinngg Preface to the Fourth Edition The 3rd edition has served its purpose well and has continued to receive international acclaim. Since its publication, however, there have been important developments, in the intensity of public interest and concern over food safety, and in legislation, not least the adoption of a range of European food hygiene directives and their implementation in the UK in the Food Safety (General Food Hygiene) Regulations 1995 and several parallel Hygiene Regulations affecting dairy products, fresh meat, meat products, poultry and game. Of major signifi cance has been the incorporation of hazard analysis critical control point ( HACCP ) principles into obligatory European and UK legal requirements. The opportunity has been taken to update the Guide in these and other respects. It is inevitable that legislative references in this Guide concentrate on Europe and the UK; but the principles outlined are of general application and may be interpreted and applied in any country in terms of its own legislation. Increasing interest in novel foods and processes and increased recognition of food aller- gens as an important food safety issue, have prompted the inclusion of two new chapters on those topics. J.R. Blanchfi eld xx PPrreeffaaccee ttoo tthhee TThhiirrdd EEddiittiioonn AA ggrraattiiffyyiinngg lleevveell ooff ddeemmaanndd rraappiiddllyy eexxhhaauusstteedd ssuupppplliieess ooff tthhee 22nndd eeddiittiioonn,, nneecceessssiittaattiinngg eeaarrllyy pprroodduuccttiioonn ooff aa 33rrdd eeddiittiioonn ooff tthhee GGuuiiddee.. TThhee ooppppoorrttuunniittyy hhaass bbeeeenn ttaakkeenn ttoo rreevviieeww tthhee GGuuiiddee wwhheerree aapppprroopprriiaattee iinn lliigghhtt ooff rreecceenntt EEuurrooppeeaann lleeggiissllaattiivvee ddeevveellooppmmeennttss ssuucchh aass tthhee EECC OOfffificciiaall CCoonnttrrooll ooff FFooooddssttuuffffss DDiirreeccttiivvee,, aanndd tthhee UUKK FFoooodd SSaaffeettyy AAcctt 11999900 aanndd tthhee vvaarriioouuss rreegguullaattiioonnss aanndd ccooddeess ooff pprraaccttiiccee mmaaddee tthheerreeuunnddeerr;; ttoo rreevviieeww tthhee tteexxttss ooff eexxiissttiinngg cchhaapptteerrss aanndd ttoo iinncclluuddee ttwwoo nneeww cchhaapptteerrss,, rreessppeeccttiivveellyy,, oonn ‘‘DDeessiiggnn ooff PPrroodduuccttss && PPrroocceesssseess’’ aanndd ‘‘IIrrrraaddiiaatteedd FFooooddss’’;; aanndd ttoo iinnccoorrppoorraattee aa nnuummbbeerr ooff ccoonnssttrruuccttiivvee ddeettaaiilleedd ssuuggggeessttiioonnss rreecceeiivveedd ffrroomm rreeaaddeerrss,, iinncclluuddiinngg ssoommee ffrroomm oouuttssiiddee tthhee UUnniitteedd KKiinnggddoomm.. OOnnccee aaggaaiinn,, oouurr tthhaannkkss ttoo oouurr ccoolllleeaagguueess oonn tthhee GGMMPP PPaanneell aanndd ttoo aallll tthhoossee wwhhoo hhaavvee ccoonnttrriibbuutteedd hheellpp oonn tthhiiss aanndd eeaarrlliieerr eeddiittiioonnss.. KK..GG.. AAnnddeerrssoonn JJ..RR.. BBllaanncchhfifieelldd Preface to the Second Edition The Institute, and especially those involved in the publication of the fi rst edition of this Guide, are delighted that demand has necessitated a second edition so quickly after its launch in June 1987. We believe that this is indicative of a real need, which the IFST has been able to meet, and we thank again all those who have supported this initiative. The original GMP Working Group has been replaced by a GMP Panel of the Technical and Legisla- tive Committee, and this Panel has effected a number of corrections and amendments to the fi rst edition, the latter largely of a clarifying nature. K.G. Anderson (Panel Convenor) J.R. Blanchfi eld xxii Decision Makers’ Summary This summary is especially addressed to the decision makers within food and drink company chair- men, presidents, chief executives, directors and general managers, who are not normally directly involved in detailed design and implementation of good manufacturing practice (GMP) systems, but whose responsibility it is to establish GMP policies and strategies for their companies, and to provide the necessary authority, facilities and resources to the functional managers and staff to implement the requirements effectively. In this Guide, GMP is considered as that part of a food and drink control operation, which is aimed at ensuring that products are safe to the consumer and are consistently manufactured to a quality appropriate to their intended use. It is thus concerned with both manufacturing and quality manage- ment procedures. The ever - increasing interest among consumers, retailers and enforcement authorities in the condi- tions and practices in food manufacture and distribution, increases the need for the food manufac- turer to operate with clearly defi ned policies. The ability to demonstrate that the principles and measures identifi ed in this Guide had been fully and effectively implemented, could, in the event of a consumer complaint or a formal prosecution, assist the manufacturer in demonstrating that all reasonable steps had been taken to prevent the cause of the complaint from occurring, or indeed avoid an offence being committed. Enlightened self - interest alone should persuade food manufactur- ers to follow these guidelines. The manufacturer of a food product must comply with the relevant legal requirements of the country for which the food is intended, for example, those of composition, of safety, of hygiene and of label- ling. While fulfi lling these, however, (s)/he has a concept of the market at which (s)/he is aiming and its requirements (e.g. in the case of a food or drink product, its appearance, fl avour, texture, presence or absence or amount of particular nutritional components, inbuilt convenience, shelf life, presentation and price). These factors determine the formulation, processing and packaging of the product. The product quality as defi ned by that concept is expressed as a product specifi cation. Conversely, the retailer may approach a manufacturer with a new product concept and request that a manufacturer design a product or process to meet the specifi c criteria. Of course, the manufacturer ’ s assessment of what the market wants may be correct or incorrect. While the concept effectively meets all of the law ’ s requirements, it may, or may not, effectively meet purchasers ’ expectations; but unless and until the manufacturer or retailer changes it, it remains the standard with which the product should conform, and GMP is designed to achieve this. Uniform conformance with product specifi cation is diffi cult with food and drink products. The main raw materials for food and drink manufacture derive from nature, and are subject to natural varia- tions. In primary production, wide variations may occur among cultivars, and also because of sea- sonal, weather and cultivation differences. In animals, apart from variations among and even within individuals, differences between breeds and rearing systems lead to variations. Therefore the additional task of the food or drink manufacturer, aided by the knowledge and skills of food science and technology, is to make a reasonably uniform product from variable raw materials by an appropriate combination of raw material selection, raw material pretreatment, formulation adjustment and processing variation. xiii

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