Food and Drink - Good Manufacturing Practice E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 455

Veröffentlichungsjahr: 2012

Beschreibung

Good Manufacturing Practice (GMP) refers to advice and guidance put in place to outline the aspects of production and testing that can impact the quality and safety of a product. In the case of food and drink, GMP is aimed at ensuring that products are safe for the consumer and are consistently manufactured to a quality appropriate to their intended use. Manufacturers have for several years been driving towards such goals as Total Quality Management (TQM), lean manufacturing and sustainability – GMP is bound up with these issues. The ever-increasing interest amongst consumers, retailers and enforcement authorities in the conditions and practices in food manufacture and distribution, increases the need for the food manufacturer to operate within clearly defined policies such as those laid down in GMP. The ability to demonstrate that Good Manufacturing Practice has been fully and effectively implemented could, in the event of a consumer complaint or a legal action, reduce the manufacturer’s liability and protect them from prosecution.

First launched in 1986, IFST’s Good Manufacturing Practice Guide has been widely recognized as an indispensable reference work for food scientists and technologists. It sets out to ensure that food manufacturing processes deliver products that are uniform in quality, free from defects and contamination, and as safe as it is humanly possible to make them. This 6^th edition has been completely revised and updated to include all the latest standards and guidance, especially with regard to legislation-driven areas such as HACCP.

The Guide is a must have for anyone in a managerial or technical capacity concerned with the manufacture, storage and distribution of food and drink. It is also a valuable reference for food education, training and for those involved in food safety and enforcement. Food scientists in academic and industry environments will value its precision, and policy makers and regulatory organizations will find it an indispensable guide to an important and multifaceted area.

About IFST

IFST is the leading independent qualifying body for food professionals in Europe and the only professional body in the UK concerned with all aspects of food science and technology. IFST members are drawn from all over the world and from all ages and backgrounds, including industry (manufacturing, retailing and food service), universities and schools, government, research and development, quality assurance and food law enforcement. IFST qualifications are internationally recognised as a sign of proficiency and integrity.

Leseprobe

Table of Contents

Cover

Title page

Copyright page

Foreword

Acknowledgements

Preface to the Sixth Edition

Preface to the Fifth Edition

Preface to the Fourth Edition

Preface to the Third Edition

Preface to the Second Edition

Decision Makers’ Summary

The Basis for GMP

Effective Manufacturing Operations

Effective Food Control

Responsible Management

PART I – GENERAL GUIDANCE

1 INTRODUCTION

2 QUALITY MANAGEMENT SYSTEM

Principle

Explanatory Note

Good Manufacturing Practice (GMP)

Food Control

Quality Management Systems

Effective Manufacturing Operations

Effective Quality Control

3 HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP)

Principle

Hygienic Practice and Prerequisite Programmes (PRPs)

HACCP

Hazard Analysis and Operability Study (HAZOP)

4 FOOD ALLERGENS

Principle

Food Allergens

5 FOREIGN BODY CONTROLS

Principle

Sources of Foreign Bodies

Prevention

Metal/Foreign Body Detection and Removal

6 MANUFACTURING ACTIVITIES

Principle

General

Process Evaluation

Production

Operator Procedures

Raw Materials

Packaging Materials

Processing and Packaging

Intermediate Products

Finished Product

Storage

Transport

7 MANAGEMENT REVIEW AND INTERNAL AUDIT

Principle

Management Review

Inputs to the Review Process

Outputs from the Review Process

Resourcing the QMS/FSMS

Legislative and Industry Guidance

Internal Audit

8 PRODUCT AND PROCESS DEVELOPMENT AND VALIDATION

Principle

Customer Requirements

Design Objectives

Regulatory Requirements

Planning

Quality Plan

Labelling

9 DOCUMENTATION

Principle

General

Quality Manual

Delivery/Intake Inspection Records

In-Process/Production and Finished Product Inspection Records

Master Forms

Control of Records Procedure

Document Approval, Amendment and Control Procedure

10 PRODUCT IDENTIFICATION AND TRACEABILITY

Principle

Product Identification

Traceability Procedure

Lot Marking Regulations

Genetically Modified Organism (GMO) Regulations

Provenance, Identity Claims and Assurance Status

11 PERSONNEL AND TRAINING

Principle

General

Qualifications

Supplier Quality Assurance

Recruitment and Selection

Training

Cessation of Employment

Food Hygiene and Personal Hygiene

Personal Hygiene Policy

Agency Staff

Ethical Trading Initiative Base Code

12 PREMISES AND EQUIPMENT

Principle

General

Premises

Equipment

Maintenance

Brittle Material Procedures

Knife/Scissors/Blade Procedures

13 WATER SUPPLY

Principle

General

Boil Water Advice

Water Sampling Procedure

14 CLEANING AND SANITATION

Principle

General

Cleaning Schedule/Procedures

Site Hygiene Plan

Cleaning in Place (CIP)

Efficiency of Cleaning

Equipment and Storage

15 INFESTATION CONTROL

Principle

UK/EU Legislation

Pest Control Programme

16 PURCHASING

Principle

General

Supplier Quality Assurance

Use of Outside Services

17 PACKAGING MATERIALS

Principle

General

Storage

18 INTERNAL STORAGE

Principle

General

Storage of Chemicals, Lubricants and Oils

19 CRISIS MANAGEMENT, COMPLAINTS AND PRODUCT RECALL

Principle

Complaints

Product Withdrawal and Recall

Emergency Procedure

Business Continuity Management

20 CORRECTIVE ACTION

Principle

General

Customer Complaints/Depot Rejections

21 REWORKING PRODUCT

Principle

General

Rejection

Relabelling

22 WASTE MANAGEMENT

Principle

General

Waste Minimisation Audit

23 WAREHOUSING, TRANSPORT AND DISTRIBUTION

Principle

General

24 CONTRACT MANUFACTURE

Principle

Contract Acceptance

Third-Party Certification

25 CALIBRATION

Principle

General

26 PRODUCT CONTROL, TESTING AND INSPECTION

Principle

General

Quantity Control

Label Control

Shelf-Life Assessment

Despatch Quality Control Procedures

Food Safety Monitoring and Verification

27 LABELLING

Principle

General

28 ELECTRONIC DATA PROCESSING AND CONTROL SYSTEMS

Principle

Implementation and Operation

Responsibility for Systems

Security

Back-Up

29 GOOD CONTROL LABORATORY PRACTICE AND USE OF OUTSIDE LABORATORY SERVICES

Principle

EU GLP

Resources

Premises

COSHH

Equipment

Cleanliness

Reagents, Controls and Standards

Sampling

Methods

Documentation

Records of Analysis

Specifications

Testing

Contract Analysis

Accreditation

30 ENVIRONMENTAL ISSUES

Principle

General

IPPC

31 HEALTH AND SAFETY ISSUES

Principle

General

PART II – SUPPLEMENTARY GUIDANCE ON SOME SPECIFIC PRODUCTION CATEGORIES

32 HEAT-PRESERVED FOODS

General

Heat Treatment

Commercial Sterility

In-Container Heat Treatment

Heat Treatment Followed by Aseptic Packaging

33 CHILLED FOODS

General

Ingredients

Product Formulation/Characteristics

Processing Parameters

Intended Use of the Product

The Chill Chain

Manufacturing Hygiene

Shelf Life

Application of HACCP

Quality Control

High-Risk Areas (HRAs)

34 FROZEN FOODS

General

Personnel and Testing Facilities

Raw Materials

Formulation

Processing

Storage

Freezing

Packaging

Cold Chain

General

35 DRY PRODUCTS AND MATERIALS

General

Grinding, Mixing and Sieving

General Hygiene

Contamination

Microbiology

Packaging and Storage

36 COMPOSITIONALLY PRESERVED FOODS

37 FOODS CRITICALLY DEPENDENT ON SPECIFIC INGREDIENTS

General

38 IRRADIATED FOODS

General

Facilities and Control of the Process

Food Quality

Application of the Process

Re-Irradiation

Import

Export

Labelling

39 NOVEL FOODS AND PROCESSES

General

40 FOODS FOR CATERING AND VENDING OPERATIONS

General

Vending

Complaints

41 THE USE OF FOOD ADDITIVES AND PROCESSING AIDS

42 RESPONSIBILITIES OF IMPORTERS

43 EXPORT

PART III – MECHANISMS FOR REVIEW OF THIS GUIDE

APPENDIX I: DEFINITION OF SOME TERMS USED IN THIS GUIDE

Analytical Method

Aseptic Processing

Batch

Batch Manufacturing Record

Batch Number

Botulinum Cook

Bulk Product

Chill Chain

Chilled Foods

Cold Chain

Commercial Sterility

Contract Manufacture

Corrective

Critical Control Point

Dehydrated Food

Detergent

Disinfection

Documentation

Extrinsic

Finished Product

Food Allergen

Food Control

Food Hygiene

Food Poisoning

Food Safety Management System

Food Spoilage

Frozen Foods

Functional

Functional Foods

Genetic Modification

Genetically Modified Organism

Good Manufacturing Practice

HACCP Plan

Hazard

Hazard Analysis

Hazard Analysis Critical Control Point

HAZOP

High-Care Area

High-Risk Area

Identity Preserved Material

Ingredients

In-Process Control

Intermediate Material

Intrinsic

Irradiated

Low-Risk Area

Manufacture

Master Manufacturing Instructions

Monitoring

Non-Conformance/Non-Compliance

Novel (Food, Process)

Nutraceutical

Packaging

Prerequisite Programme

Preservation Index

Preventive Action

Processed

Processing Aid

Quality Assurance

Quality Control

Quality Management System

Quarantine

Radiation Dose

Raw Material

Ready to Cook

Ready to Eat

Ready to Reheat

Re-Validation

Reworking

Risk

Risk Assessment

Root Cause Analysis

Specification

Starting Material

Validation

Verification

APPENDIX II: ABBREVIATIONS USED IN THE GUIDE

APPENDIX III: LEGISLATION AND GUIDANCE

Websites

APPENDIX IV: ADDITIONAL REFERENCES

APPENDIX V: LIST OF ORGANISATIONS AND INDIVIDUALS FROM WHOM HELP, INFORMATION OR COMMENT HAS BEEN RECEIVED

GMP Working Group Members

Members of Working Groups for Previous Editions

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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 simplified, 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 beneficial within a wider business context and simultaneously improve good practice. I am confident that this will lead to even more efficient practice and better food safety across the sector. Greater confidence in the entire manufacturing process will mean we can have more confidence 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

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 enlightening 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 manufacturing 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 management 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 monitoring and verification activities. Without these fully functioning and integrated dynamics being in place, due diligence cannot be actively demonstrated.

Louise Manning

Preface to the Fifth Edition

The 5th edition has been developed to meet the various changes in stakeholder requirements of the UK Food Industry since 1998. These include the further development of the European Union (EU) legislation, the establishment of the Food Standards Agency and the Department of the Environment and Rural Affairs [DEFRA to replace the Ministry of Agriculture, Fisheries and Food (MAFF)]. There has also been the development of third-party quality management standards in the food supply chain such as the British Retail Consortium (BRC) Global Standard—Food and establishment of the Global Food Safety Initiative (GFSI) and the introduction of BS EN ISO 22000:2005 Food safety management systems. The 5th edition addresses the need to meet these changes including the requirement for key prerequisite programmes in food manufacture with new or updated chapters on manufacturing activities, cleaning and sanitisation, personnel and training, infestation control, calibration and foreign body controls. Increasing globalisation of food supply chains has required UK businesses to focus on not only product safety, legality and quality but also the need to drive continuous improvement. Sustainable food businesses need to address these issues to produce safe, wholesome food of a consistent quality that meets customer expectations.

L. Manning

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 significance 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 allergens as an important food safety issue, have prompted the inclusion of two new chapters on those topics.

J.R. Blanchfield

Preface to the Third Edition

A gratifying level of demand rapidly exhausted supplies of the 2nd edition, necessitating early production of a 3rd edition of the Guide. The opportunity has been taken to review the Guide where appropriate in light of recent European legislative developments such as the EC Official Control of Foodstuffs Directive, and the UK Food Safety Act 1990 and the various regulations and codes of practice made thereunder; to review the texts of existing chapters and to include two new chapters, respectively, on ‘Design of Products & Processes’ and ‘Irradiated Foods’; and to incorporate a number of constructive detailed suggestions received from readers, including some from outside the United Kingdom. Once again, our thanks to our colleagues on the GMP Panel and to all those who have contributed help on this and earlier editions.

K.G. Anderson

J.R. Blanchfield

Preface to the Second Edition

The Institute, and especially those involved in the publication of the first 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 Legislative Committee, and this Panel has effected a number of corrections and amendments to the first edition, the latter largely of a clarifying nature.

K.G. Anderson (Panel Convenor)

J.R. Blanchfield

Decision Makers’ Summary

This summary is especially addressed to the decision makers within food and drink company chairmen, presidents, chief executives, directors and general managers, who are not normally directly involved in detailed design and implementation ofgood 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 management procedures.

The ever-increasing interest among consumers, retailers and enforcement authorities in the conditions and practices in food manufacture and distribution, increases the need for the food manufacturer to operate with clearly defined policies. The ability to demonstrate that the principles and measures identified 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 manufacturers 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 labelling. While fulfilling 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, flavour, 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 defined by that concept is expressed as a product specification. 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 specific 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 specification is difficult with food and drink products. The main raw materials for food and drink manufacture derive from nature, and are subject to natural variations. In primary production, wide variations may occur among cultivars, and also because of seasonal, 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.

The Basis for GMP

GMP has two complementary and interacting components: the manufacturing operations and the quality management system [which, for the purposes of this Guide, the Institute of Food Science & Technology (IFST) has designated ‘food control’] (see Figure 1). Both these components must be well designed and effectively implemented. The same complementary nature and interaction must apply to the respective management of these two functions, with the authority and responsibilities of each clearly defined, agreed and mutually recognised. This is not to disregard the importance of other key functions essential to the effective functioning of a company, or indeed of those functions contributing direct services or advice to the manufacturing operation (e.g. purchasing, cost accounting, work study, production planning and engineering maintenance).

Figure 1

What constitutes ‘well designed’ in these two contexts mentioned above is not just a matter of common sense, or something that would be self-evident to non-technical business people. As well as management skills, it also involves extensive and up to date knowledge of current and emerging food safety hazards and food science and technology as relating to the ingredients, processes, packaging and products concerned.

Effective Manufacturing Operations

GMP requires that every aspect of manufacture is fully defined in advance; and that all the resources and facilities are specified—namely:

specific measures undertaken at critical control points (CCPs) based on food safety hazard analysis;

adequate design of premises and suitable manufacturing and storage space;

suitable process flow with process design to streamline the process and minimise the potential for cross-contamination;

correct and adequately maintained equipment;

appropriately trained people;

correct raw materials, processing aids and packaging materials;

appropriate storage and transport facilities;

documented operational procedures and cleaning schedules;

appropriate management and supervision; and

adequate technical, administrative and maintenance services

are provided, in the right quantities, at the right times and places, and are utilised as intended. In order to ensure that operations do proceed according to plan, it is also necessary to:

provide operators with documented procedures in clear unambiguous instructional language (with due regard to reading, numeracy and language problems);

train and motivate the operators to carry out the procedures correctly;

undertake formal review to ensure that training has been effective;

avoid, if possible, incentive bonus schemes, but, if unavoidable, to build into any incentive bonus scheme adequate safeguards against unauthorised ‘short cuts’;

provide a food control programme working along the lines indicated below;

ensure that genuine records are completed during production and that they demonstrate that specified procedures were in fact complied with, and to enable the history of manufacture and distribution of a batch subsequently to be traced should a problem arise or a product withdrawal or recall be necessary;

establish a well-planned and effective system to carry out a product withdrawal or recall, should that prove necessary; and

establish a tried and proved business continuity and crisis management procedure in case of need.

Effective Food Control

The other and complementary major component of GMP is effective food control. Effectiveness requires:

well-qualified and appropriately experienced food control management participating in the development and validation of process controls and specifications;

competent staff and adequate facilities to do all the relevant inspection, sampling and testing of materials, and monitoring of process conditions and relevant aspects of the production environment (including all aspects of hygiene) and management of potential food safety hazards;

verification activities to be developed and implemented by appropriately experienced personnel in order to demonstrate that the food products and the process are under the appropriate level of control; and

rapid feedback of information (accompanied where necessary by advice) to manufacturing personnel, thereby enabling prompt adjustment or corrective action to be taken, and enabling processed material to be approved as fit for either further processing or sale, or to be segregated for decision as to appropriate disposition, for example, reject, regrade or reprocessing.

Responsible Management

Of course, the requirements of effective manufacturing operations and of effective food control mentioned above are merely headings; and within each there are very many aspects that are considered more fully within the body of this Guide. The Institute hopes that the Guide will prove of help to the management of food and drink companies, to those concerned with private and public verification activities, food law enforcement and consumer protection, to the students who will be the food technologists, engineers and production managers of tomorrow and to those responsible for training them.

The full title of the Guide is ‘Food & Drink – Good Manufacturing Practice: A Guide to its Responsible Management’. The reference to responsible management is deliberate. GMP can only stem from policy firmly and uncompromisingly stated and continuously pursued by a company board and general management, which, moreover, provides adequate physical, financial and human resources for the purpose.

PART I – GENERAL GUIDANCE

1 

INTRODUCTION

1.1 

The purpose of this Guide is to outline the responsibilities of managers in relation to the efficient manufacture and control of food and drink products, thereby ensuring that such products are safe, wholesome and of the nature and quality intended. While it addresses manufacture of food and drink for use in the catering and vending industries, it does not deal with catering and retail activities per se. The Guide is therefore particularly concerned with advice to management on: