In the United Kingdom we all depend upon the food industry, our largest manufacturing sector, to deliver high standards when it comes to food that is safe to eat, and food that is what it says it is. We all want the public to be able to trust the food they eat, at home and whilst out and about. It is the industry’s responsibility to ensure that food is safe and authentic, and to deliver and sustain strong foundations for public trust in food.

The 7th edition of the IFST Guide to Good Manufacturing Practice is an important resource for food businesses. With thorough and detailed guidance, it sets out how businesses meet their legal obligations and shows how to deliver public confidence and trust. I welcome the increased focus on food authenticity and integrity in this edition, which will help to protect businesses and consumers alike from the risks of food fraud. It is an area we at the Food Standards Agency are also focused on. We wish to extend the remit and scale of the National Food Crime Unit, working in partnership with other agencies, and we are revitalising our surveillance approach to keep pace with constant change in our national and global food system. Regulation needs to adopt new and innovative ways of delivering, and to keep refreshing the relationships between regulator and industry to succeed against new threats and challenges. This guide will help business get it right, and help us all deliver a safe, secure and trusted food sector into the future.

The 6th edition built on previous editions and provided additional content in the area of food safety management systems and quality management systems, their design, validation, implementation and verification. Consideration of what good manufacturing practice (GMP) is, and evolves to be, has led to the need for a number of new chapters in this 7th edition. The melamine incident in China, fipronil in eggs and the horsemeat incident 2013 in Europe has caused food manufacturing organisations, the food supply chain and those involved in wider food policy development and implementation to consider issues around food integrity, food crime and general malpractice in the food chain and how protocols to mitigate risk need to be included within GMP. The rapid development in testing programmes to demonstrate the provenance of food materials and food products means that manufacturers can now more easily verify labelling information and the claims they make on their products. As a result, the 7th edition focuses on the growing interest in food integrity management systems and how manufacturers need to demonstrate they have done everything reasonable to ensure the integrity of their products, the processes they employ, the data and information they often rely upon, and the people who undertake the tasks critical to ensuring food safety, legality and quality.

A list of many of the organisations and individuals from whom help, information or comment has been received for this edition 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, made an enormous contribution to the development of the 5th and 6th editions of this Guide.

As with the previous editions that I have edited, the preparation of this 7th edition has been an enjoyable and thought‐provoking experience.

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 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 that is aimed at ensuring that products are safe, legal, meet integrity criteria and are of the required quality. Effective GMP ensures that products are consistently manufactured to a quality appropriate to their intended use. It is thus concerned with manufacturing practices, food safety, legality, quality and integrity management systems.

The ever‐increasing interest among consumers, retailers, enforcement authorities and other stakeholders such as insurers or shareholders in the conditions and practices employed in food manufacture and distribution heightens the need for the food manufacturer to operate with a clearly defined strategy with high‐level policies together with associated operational procedures and protocols. The ability to demonstrate that the principles and measures identified in this Guide have been fully and effectively implemented could, in the event of a product incident, consumer complaint or formal prosecution, assist the manufacturer in demonstrating that all reasonable steps had been taken to prevent the cause of the incident 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, safety, hygiene and labelling. While fulfilling these, however, she/he has a concept of the market at which she/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. Product quality is defined in a product specification that should encompass all of these requirements and express them in a clear, unambiguous manner.

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, the product specification remains the standard with which the product should conform, and GMP is designed to achieve this.

Uniform conformance with product specifications 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 differences between individuals, variance between breeds and rearing systems leads to the potential for inconsistency. 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 out variation which is outside the boundaries of the product specification.

The Basis for GMP

GMP has two complementary and interacting components: the manufacturing operations and wider management systems [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). These terms are explored in more detail in Chapter 2.

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 quality issues, food safety hazards and best practice in terms of food science and technology 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 and food integrity threat analysis, or critical quality points (CQPs) identified in the quality planning process;
• 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 and instruction have been effective;
• avoid, if possible, incentive bonus schemes, but, if unavoidable, to build into any incentive bonus schemes adequate safeguards against unauthorised ‘short cuts’ or trade‐offs;
• 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 individuals working in food control management participating in the development and validation of process controls and specifications that address the safety, legality, quality and integrity of food;
• competent staff and adequate facilities to undertake 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 and food integrity threats;
• verification activities that are developed and implemented by appropriately experienced personnel in order to demonstrate that the food products and the process are consistently under the appropriate level of control and identify areas for preventive action where system weaknesses and vulnerabilities are detected; 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.

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 retail, catering and vending industries, it does not deal with catering and retail activities per se. The Guide is therefore particularly concerned with management practices associated with:

• factors affecting product safety, product legality, product integrity and product quality;
• product manufacture in terms of product and process control and handling of food under hygienic conditions in conformity with product, packaging and labelling specifications; and
• matters such as training of personnel, documentation and record keeping, supplier approval, suitability of premises and equipment and site standards, waste avoidance, recovery and reworking of materials, laboratory management, traceability, verification activities, and preventive and corrective action and the management of customer complaints and product recall.

1.2 It is emphasised that the Guide is concerned with advice based on principles of good manufacturing practice (GMP), and it is recognised that methods other than those described, but which achieve the same ends, may be equally acceptable. Personnel and premises hygiene, because of its importance, is treated as a continuous theme and a subject for consideration throughout the document.

The Guide is in three parts:

• Part I: deals with matters of general application;
• Part II: deals with guidance on specific manufacturing and/or food categories; and
• Part III: covers mechanisms for review of the Guide.

1.3 The Guide does not deal directly with such matters as operative safety and welfare, ethical matters, animal welfare or environmental issues including water and energy conservation. It refers to resource management and waste control, engineering, maintenance and transport and distribution only in respect of those aspects that have a bearing on manufacturing practices. In general it does not deal with matters unrelated to scientific, technological and organisational aspects affecting product safety, product legality, product integrity and product quality.

1.4 The Guide has been written at a time when the United Kingdom (UK) is negotiating a new relationship with the European Union (EU) in terms of legislative harmonisation and trade agreements. To this end legislation still in force at the time of writing has been referenced, but may change post publication of this Guide. This is true of any legislation and/or policy approach in a given country or trading group when referenced by a static publication. The principles of GMP are universal and in many ways transcend the specifics of one nation’s current or emerging legislation. Food manufacturers supplying internationally need to be aware of not only the legislation in the country in which they are manufacturing, but also the need for the products produced to comply with the legislation in countries to which they seek to export. There are many instances of product recalls in countries as a result of food products, for example, not complying with the export countries’ requirements for food allergen labelling for ingredients such as celery, mustard or milk. It is the responsibility of the reader to refer to current legislation itself or review the contents of this Guide with the support of a competent adviser, and not to rely on an interpretation or an abridged version of legislative requirements as given in this document.

1.5 Absolute terms, such as ‘ensure that’, ‘avoid’, ‘prevent’, ‘absence of’ and so on, have been used in various parts of the Guide. To dispense with them would detract from the intentions of the Guide or would necessitate lengthy explanations on each occasion. Accordingly, readers should note that such terms are to be interpreted in a rational and practical way, for example ‘ensure that’ should be read as meaning ‘ensure, so far as is reasonably practicable, that’. Words such as ‘should’ are used for non‐mandatory advice, and the imperative, for example ‘must’ or ‘shall’, is reserved for appropriate mandatory requirements.

1.6 Definitions of some of the terms used in this Guide are given in Appendix I. It is appreciated that other definitions may be equally valid or preferred, and the appendix definitions are simply intended to clarify the meanings attributed to a word or phrase when used in the compilation of the Guide.

1.7 The Guide is an advisory document with a list of supporting, supplementary references. The Guide may be particularly useful to students studying food manufacture, to new entrants to management and to general managers in smaller companies who may be responsible for a range of management functions, each of which may be the sole concern of one or more specialist senior managers in a larger company as well as regulatory officers.

1.8 GMP is not a static concept, but an evolutionary, dynamic mechanism by which overall improvements in manufacturing controls can be developed, implemented and maintained.

1.9 The Guide outlines general principles that may already be contained in published guidelines or codes of practice. As appropriate, the Guide will provide references to the original sources that the reader is then advised to consult in full. The Guide will also make reference, where appropriate, to international private standards such as those developed by the Codex Alimentarius Commission.

1.10 The initial adoption of the EC Official Control of Foodstuffs Directive and the advent of the UK Food Safety Act 1990 as well as existing provisions of the UK Trade Descriptions Act and the UK Weights and Measures Act gave increasing emphasis to the need for a manufacturer to be able to prove that (s)/he did everything necessary to comply with the law. Thus under the UK Food Safety Act 1990, and other subsequent legislation, a manufacturer, retailer or importer charged with an offence may enter the legal defence that (s)/he ‘took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by the accused or by a person under the control of the accused’. In this context, it can be considered that ‘precautions’ are the measures taken and ‘diligence’ is the activities undertaken to ensure their effective application. The wording puts the onus of proof on the defendant, and both must be proved and the use of the word ‘all’ implies that ‘some’ or ‘most’ will not be enough. What constitutes ‘all reasonable precautions and all due diligence’ in a particular instance must relate to the nature of the offence and to other related circumstances. Nevertheless in the case of a safety or a ‘nature, substance or quality’ offence, a manufacturer who can prove that (s)/he has diligently installed and appropriately applied all the relevant measures in the Institute of Food Science & Technology (IFST) Guide to Good Manufacturing Practice will stand a very good chance of having a successful defence. It must also be pointed out that a manufacturer who does not employ appropriate technically competent personnel to specify the product formulation, factory processes and procedures to design and control the continuous monitoring of their correct operation and undertake such validation and verification activities cannot be said to have exercised either adequate precautions or adequate diligence and is unlikely to have a successful defence.

1.11 Responsibility for enforcement within the EU varies from country to country. In the UK it is shared between central, devolved and local government bodies. While the making of legislation in the UK is the function of central and devolved government, the enforcement of food law is primarily (but not solely) the responsibility of more than 400 local authorities (LAs) in the UK, and more specifically LA officers. LA officers can be differentiated as being environmental health officers (EHOs) and trading standards officers (TSOs). The Food Standards Agency (FSA) has a statutory requirement, in consort with other government bodies, to protect public health and consumers’ interests in relation to food. Since the publication of the last version of the GMP Guide (Version 6) there has been a policy review with regard to food regulation to move to a more risk‐based approach. A risk‐based approach is well established in UK food regulation, for example the food establishment intervention rating schemes. This trend is also considering the use of public and private regulatory activities to develop a form of co‐regulation. This would include utilisation of information from both public enforcement activities (e.g. EHO inspections) and information from private surveillance and verification activities such as third‐party audits and product sampling activities.

The roles and responsibilities of all the authorities and organisations in the UK involved in monitoring compliance with, and enforcement of, feed and food law, plant health and feed and food law are set out in the Multi‐Annual National Control Plan (MANCP) for the UK. It is a requirement of Regulation (EC) No. 882/2004 that all EU member states have such a national control plan in place. The MANCP is produced jointly by the FSA and the Department for Food and Rural Affairs (Defra), with contributions from national and devolved agencies. The paragraphs below are a broad overview of the UK legislative framework relating to food manufacture and specific arrangements may be different within a geographical area or industry sector so this should be considered when reading this Guide.

The Framework Agreement on Official Feed and Food Controls by LAs provides the FSA with the processes required to implement its powers under the Food Standards Act 1999. This agreement gives structure to the FSA’s supervision of LA enforcement work. The Food Law Code of Practice (FLCP) sets out the way LAs should apply food law, and how they should work with food businesses. LAs must follow and implement appropriate provisions of the Code. Practical guidance is also provided as a further help to enforcement officers.

The EHOs and TSOs are authorised by their LAs to enforce food legislation. Once they achieve certain qualifications, detailed under the FLCP, they are authorised to carry out certain tasks and are provided with powers (under the Food Safety and Hygiene (England) Regulations 2013 and other equivalent UK legislation as amended) to, for example, enter premises, take samples, gather evidence, issue notices and, under certain circumstances, close premises.

Depending on the structure of local government in the area in England and Wales, food visits may be from TSOs to examine labelling, compositional standards and food contaminants, and EHOs to check on food hygiene. However, in Scotland, Northern Ireland and some Welsh and English authorities, EHOs are responsible for all the food legislation, with TSOs responsible for weights and measures checks. Further, in some areas LAs have combined their resources to a single unit which operates over a number of LA areas. It is incumbent on the manufacturer to be aware of the local regulatory framework in the area in which they operate, to have registered their food business and to comply fully with all requirements. Visits to manufacturing sites by LA officers are to ensure compliance with legislation; the frequency of interventions (visits) to a given manufacturing site is determined as previously described by a risk‐based approach.

The actual policy and resources allocated to the inspection premises and sampling of product will depend on the individual LA and therefore there are variations in delivery across the country. However, businesses should be able to benefit from a positive relationship with enforcement authorities, receiving detailed written feedback following inspections and receiving results of sampling exercises. Some companies develop a ‘Home Authority’ or ‘Primary Authority’ agreement with their LAs. In the UK, the Better Regulation Delivery Office’s (BRDO) Primary Authority Scheme gives businesses the right to form a statutory partnership with a single LA that then provides ‘robust and reliable advice for other councils to take into account when carrying out inspections or dealing with non‐compliance’ (see https://www.food.gov.uk/enforcement/enforcework/compliance/primary‐auth).

The European Union (EU) Official Controls Regulation 2017/625 entered into force on 27 April 2017 and replaces Regulation (EC) No. 882/2004 on official controls and other legislation. It becomes applicable over time with the main application date being 14 December 2019.¹This Regulation addresses official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products. The Regulation establishes a single legislative framework for the organisation of official controls performed for the verification of compliance with the rules established at EU level or by Member States seeking to apply EU legislation.

1.12 Abbreviations, for example GMP, have been used in the text throughout the Guide, but have been reconfirmed at the start of each chapter in case the chapter is read in isolation and therefore to minimise the number of times that the reader has to refer to the abbreviations list (Appendix II).