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Title: email :akamil@ju.edu.jo


1
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  • email akamil_at_ju.edu.jo
  • Food and Drink Good Manufacturing Practice

2
GMP 5Food and Drink Good Manufacturing Practice
  • A Guide to its Responsible Management
  • 1987 IFST 1st Edition ISBN 0 905367 02 2
  • 1989 IFST 2nd Edition ISBN 0 905367 04 9
  • 1991 IFST 3rd Edition ISBN 0 905367 08 1
  • 1998 IFST 4th Edition ISBN 0 905367154
  • 2006 IFST 5th Edition ISBN 0 905367 20 0
  • This Guide is of an advisory nature. It has been
    compiled by the Institute of Food Science
    Technology in consultation with other interested
    bodies.

3
CONTENTS

  • Page
  • Acknowledgements
    vi
  • Prefaces
  • Decision Makers Summary
    ix
  • Part I General Guidance
  • Chapter 1 Introduction
    1
  • 2 Quality Management System 5
  • 3 Hazard Analysis Critical
  • Control Point (HACCP)
    10
  • 4 Food Allergens
    15
  • 5 Foreign Body Controls
    20
  • 6 Manufacturing Activities
    26
  • 7 Management Review and
  • Internal Audit
    36

4
  • 8 Product and Process Development and Validation
    39
  • 9 Documentation
    42
  • 10 Product Identification and Traceability
    50
  • 11 Personnel and Training
    53
  • 12 Premises and Equipment
    63
  • 13 Water Supply
    73
  • 14 Cleaning and Sanitation
    76
  • 15 Infestation Control
    83
  • 16 Purchasing
    89
  • 17 Packaging Materials
    93
  • 18 Internal Storage
    95
  • 19 Crisis Management Complaints and Product
  • Recall
    98

5
  • 20 Corrective Action
    104
  • 21 Reworking Product
    107
  • 22 Waste Management
    111
  • 23 Warehousing, Transport and Distribution
    113
  • 24 Contract Manufacture
    118
  • 25 Calibration
    120
  • 26 Product Control, Testing and Inspection
    123
  • 27 Labelling
    127
  • 28 Electronic Data Processing and Control Systems
    130
  • 29 Good Control Laboratory Practice
  • and Use of Outside Laboratory Services
    133
  • 30 Environmental Issues
    139
  • 31 Health Safety Issues
    141

6
  • Part II Supplementary Guidance
  • on Some Specific Production Categories
  • Chapter 32 Heat Preserved Foods
    143
  • 33 Chilled Foods
    152
  • 34 Frozen Foods
    161
  • 35 Dry Products and Materials
    167
  • 36 Compositionally-preserved Foods
    170
  • 37 Foods Critically Dependent on Specific
  • Ingredients
    171
  • 38 Irradiated Foods
    173
  • 39 Novel Foods and Processes
    178
  • 40 Foods for Catering and Vending Operations
    183
  • 41 The Use of Food Additives and Processing Aids
    185
  • 42 Responsibilities of Importers
    188
  • 43 Export
    190

7
Food Drink - Good Manufacturing Practice A
Guide to its Responsible Management PART I
GENERAL GUIDANCE1. INTRODUCTION
  • 1.1 The purpose of this guide
  • It 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.

8
1.2 GMP Definition
  • GMP is considered as that part of a food and
    drinkcontrol operation aimed at ensuring that
    products are consistently manufactured to a
    quality appropriate to their intended use.
  • It is thus concerned with both manufacturing and
    quality control procedures.

9
1.3 GMP two pillars
  • It is evident that GMP has two complementary,
    and interacting components (two pillars)
  • the manufacturing operations and the quality
    control/quality assurance system (which, IFST has
    designated 'food control').
  • This is not to ignore the importance of other 41
    topics covered by the GMP such as exporting,
    foreign matters control, good laboratory
    practice, warehousing .etc.

10
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11
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12
2 QUALITY MANAGEMENT SYSTEM
  • Principle
  • There should be a comprehensive management
    system, so designed, documented, implemented,
    reviewed and continuously improved, and so
    furnished with personnel, equipment and
    resources, as to ensure that specifications set
    to achieve the intended product quality
    standards are
  • consistently met.
  • The attainment of this quality objective
    requires the involvement and commitment of all
    concerned at all stages of manufacture.

13
  • Explanatory Note
  • 2.1 A manufacturer has to comply with the legal
    requirements relevant to his product.
  • While embracing these, s/he will have determined
    the market requirement which s/he aims to meet,
    and therefore the product quality standard.
  • The established product specification embodies
    both legal requirements (for example those of
    composition, safety, hygiene and labeling) and
    market requirements.

14
  • Market requirements may include aspects such as
    product nature, appearance, flavor, texture,
    presence or absence and quantity of particular
    nutritional components, nature of pack, pack
    size, degree of inbuilt convenience, shelf-life,
    presentation and price.
  • While some commercial and marketing
    considerations affecting the market requirement
    specification are outside the scope of this
    Guide, those relating to the principles of design
    and development of products and processes to
    comply with that specification are dealt with in
    Chapter 8.

15
  • The product and process design, when completed
    and validated, then becomes a part of the full
    product specification. Once established it
    remains permanent until formally changed.
  • All references in this Guide to compliance with
    product specifications imply compliance with all
    of the foregoing requirements embodied in the
    specification.
  • 2.2 In order to achieve the objectives of good
    manufacturing practice, it is necessary to have
    in place

16
  • 1. Quality Assurance
  • to design and plan, as relevant,
  • raw material specifications,
  • ingredients formulation,
  • adequate resources such as processing equipment
    and environment,
  • processing methods and conditions,
  • intermediates specifications,

17
  • appropriate packaging and labeling
    specifications,
  • specification for quantity per pack,
  • specifications for management and control
    procedures,
  • a specified distribution system and cycle, and
  • appropriate storage, handling and preparation
    instructions,
  • which, taken all together, are capable of
    resulting in products complying with the product
    specification

18
  • 2. Effective Manufacturing Operations to manage
    the operational production/ distribution
    practices so as to ensure that the capability is
    translated into reality i.e. that the process
    adheres to its specified design parameters and
    that the resulting products actually do comply
    consistently with the product specification
  • 3. Quality Control
  • to have in place an effective monitoring system
    that verifies compliance with specified
    requirements, and defines suitable corrective
    action in the event of out-of control
    occurrences.

19
  • Good Manufacturing Practice2.3 Thus, Good
    Manufacturing Practice may be viewed as having
  • two complementary components, namely effective
    manufacturing operations, and effective food
    control (see Figure 1, page x).
  • Food Control
  • 2.4 The Institute of Food Science Technology
    (IFST) uses the term food control to describe a
    comprehensive quality and food safety system
    based on the principles of HACCP which interlinks
    with quality assurance and quality control in a
    quality management system.

20
  • Quality Management Systems
  • 2.5 Many manufacturers will have developed their
    own quality management systems, but increasingly
    are attaining or seeking to attain certification
    to a third party quality management system
    standard.
  • EN ISO 90002008 is an international quality
    system standard and it describes the requirements
    of a quality management system to assure
    conformance of product and production to
    specified requirements.

21
  • Quality management system standards have been
    developed specifically for food manufacturing
    especially with increasing globalization of food
    production.
  • These include BS EN ISO 220002005 Food safety
    management systems, the British Retail Consortium
    (BRC) Global Standard Food and the Global Food
    Safety Initiative (GFSI) Standard developed to
    benchmark international third party standards.

22
  • Effective manufacturing operation 2.6 An
    effective manufacturing operation is one where,
    as appropriate-
  • (a) the manufacturing process, equipment,
    activities, precautions, etc., are fully
    specified in advance, and systematically reviewed
    in light of experience
  • (b) the necessary facilities and resources are
    provided, including
  • (i) appropriately qualified personnel
  • (ii) adequate premises and space
  • (iii) suitable equipment and services
  • (iv) specified materials, including packaging

23
  • (v) specified policies and procedures, including
    cleaning procedures and
  • (vi) suitable storage and transport.
  • (c) the relevant written procedures are provided,
    in instructional
  • form and using clear and unambiguous language,
    and are
  • specifically applicable to the facilities
    provided

24
  • (d) operators are trained to carry out the
    procedures correctly
  • (e) records are made (whether manually or by
    recording instruments or both) during all stages
    of manufacture, which demonstrate that all the
    steps required by the defined procedures were in
    fact carried out, and that the quantity and
    quality produced were those expected

25
  • (f) records are made and retained in legible and
    accessible form which enables the history of the
    manufacture and distribution of a batch to be
    traced and
  • (g) a system is available to recall from sale or
    supply any batch of product, if that should
    become necessary.

26
  • Effective Quality Control
  • 2.7 Quality Control is the function concerned
    with determining the
  • compliance of the finished products with
    specification and with activities ancillary
    thereto.
  • It includes the undertaking of inspections and
    tests to determine the degree of compliance with
    specifications, examination of process control
    data, and the provision of rapid information and
    advice leading to corrective action when
    necessary.
  • The term is also used to designate the department
    responsible for this function.

27
  • (N.B. What is described below does not preclude
    automatic process adjustment by negative feedback
    from automatic process monitors/recorders, or
    production operators receiving such information
    on-screen and themselves taking appropriate
    action, provided that they are suitably trained,
    that such procedure is written into the Quality
    Control system and that any actions are
    recorded).

28
  • 2.8 Effective Quality Control requires that,
    where appropriate,
  • (a) the Quality Control Manager participates
    (with others as necessary) in the development and
    approval of specifications, liaises with
    suppliers in agreeing specifications, and
    assesses and approves suppliers on the basis of
    their ability to supply reliably in compliance
    with the specifications

29
  • (b) adequate resources, facilities and staff are
    available for sampling, inspection, testing and
    sensory assessment of starting materials
    (including packaging materials), intermediates
    and finished products, and for monitoring process
    conditions and relevant aspects of the production
  • environment (including all aspects of
    hygiene)
  • (c) all samples for inspection and testing are
    collected by personnel under the direction of,
    and examined with methods approved by, the
    Quality Control Manager.

30
  • The results of such examination need to be
    formally assessed against the specification by
    the Quality Control Manager or a person
    designated by him/her
  • (d) established procedures exist whereby starting
    materials and intermediates are approved for use,
    rejected, or designated for treatment intended to
    bring them within specification, according to
    inspection/test results obtained

31
  • (e) there is rapid feedback of information
    (accompanied where
  • appropriate, by advice) to manufacturing
    personnel, enabling prompt adjustment or
    corrective action to be taken when necessary and
    to the purchasing function in respect of raw
    material lots
  • (f) a positive release procedure exists, where
    appropriate, whereby batches of finished product
    are temporarily quarantined until formally
    released for rectification, or into normal stock,
    or for distribution

32
  • (g) sufficient reference samples of starting
    materials or records of the result of their
    inspection where deterioration could occur,
    should be retained to permit future examination
    if necessary
  • (h) sufficient reference samples of finished
    products are retained for shelf-life tests and to
    permit future examination if necessary
  • (i) customer/consumer complaint samples are
    examined, the causes of defects investigated
    where possible, and appropriate measures advised
    for corrective action to prevent recurrence

33
  • (j) summaries of quality performance data in
    appropriate form are provided by Quality Control
    to operating functions (e.g. general management,
    production management, purchasing, and cost
    accounting).
  • These summaries may provide input in the
    determination of quality objectives for the
    business whereby data are routinely analyzed to
    determine performance against defined targets and
    potentially identify areas for improvement

34
  • (k) a direct interest is taken in the activities
    and quality assurance procedures of the suppliers
    of raw materials and packaging materials, and
    close contact is maintained with their Quality
    Assurance Departments
  • (l) ongoing contact is maintained with the
    relevant enforcement authorities and matters
    raised by them are investigated and responded to
    in the UK the Food Standards Agency (FSA) and the
    Home Authority will provide useful contacts

35
  • (m) due heed is taken of new developments in food
    legislation, especially on changes in
    compositional standards and labeling requirements
    which may necessitate changes to specifications
    for raw materials or finished products, and on EU
    and UK Government proposals for future food
    legislation and
  • (n) the authority and responsibilities of the
    Production Management and the Quality Control
    Management functions respectively are clearly
    defined so that there is no misunderstanding..

36
3. FOREIGN BODY CONTROLS
  • Principle
  • The protection of food against contamination with
    foreign bodies requires the use of HACCP to
    identify potential sources, with assessment of
    the types of foreign bodies associated with them
    and their degree of seriousness.
  • It is important to determine if the foreign
    bodies are intrinsic i.e. derived from the
    product e.g. fruit stones or fish bone or
    extrinsic i.e. derived from the environment as
    the method of control will be different.

37
  • Preventive methods are progressively applied at
    various points in the process flow,
    manufacturing, packaging, storage and
    distribution chain to minimize the risk of the
    presence of foreign bodies in the product.
  • While the use of automatic inspection devices
    (metal detectors, X-ray machines and vision
    systems) is recommended as appropriate, it must
    be remembered that none of these devices is
    capable of detecting all foreign body
    contaminants.

38
  • practice.
  • The major emphasis must always be prevention.
  • Foreign body control procedures are a key
    prerequisite to ensure good manufacturing
  • Sources of Foreign Bodies
  • 3.1 It is convenient for practical control to
    divide sources of foreign bodies into those
    external to the manufacturing plant and those
    within the plant and premises.
  • Incoming materials and their packaging from
    external sources become potential internal
    sources immediately they enter the manufacturing
    premises.

39
  • 3.2 External sources are frequently associated
    with characteristic contaminants such as pest
    predators on fruits and vegetables or parasites
    in animals.
  • Similarly, particular methods of production,
    handling and packaging of incoming materials can
    give rise to characteristic foreign bodies, for
    example metal or plastic tags in carcass meat,
    stones in root crops or slivers of wood in herbs
    or tea packed in chests.

40
  • Incoming materials arrive in containers
  • made from metal, glass, plastic, textile,
    paper or cardboard and are often on wooden
    pallets.
  • Risk assessment of a material will identify the
    potential hazards associated with it and its
    packaging and pallets, and the appropriate action
    necessary to minimize their effects.
  • Preventive measures should start at the source of
    supply and all raw material specifications should
    include considerations concerning foreign body
    control and limitation.

41
  • The types of physical contamination which need to
    be considered include glass, ceramic, plastic
    (hard and soft), wood, metal, paint, paper,
    cardboard, string, stones, pests and parts of
    pests and human-origin foreign bodies.
  • 3.3 Internal sources of foreign bodies include
    the following-
  • (i) the building and installations

42
  • (ii) the plant and equipment
  • (iii) surface coatings and finishes
  • (iv) extraneous materials - cleaning materials,
    tools, spare parts, etc.
  • (v) personnel
  • (vi) pest infestation and
  • (vii) recovered or reworked product.

43
  • Prevention
  • 3.4 Preventive concepts should be considered in
    -
  • (i) the design of plant, equipment and buildings
    and their maintenance
  • (ii) personnel training and management
  • (iii) housekeeping and general hygiene and
  • (iv) processing and packaging.

44
  • 3.5 The examination and analysis of quality
    control data and consumer complaints records
    should be used to monitor the effectiveness of
    preventive action.
  • 3.6 All plant, equipment and buildings should be
    inspected regularly to ensure that nothing has
    deteriorated, become dirty, or become detached,
    or is likely to do so, and thereby create a risk
    of
  • contamination of a product.

45
  • 3.7 Personnel should be instructed and encouraged
    to report immediately any incident of
    contamination or potential contamination of the
    product.
  • 3.8 Personnel must be issued with suitable
    protective clothing.
  • Overalls should have internal pockets and
    non-detachable fastenings.
  • Loose items, unless required to carry out
    necessary work, should be banned in production
    areas.
  • All wrist watches and jewellery should be
    prohibited, although plain wedding rings and
    secure sleeper earrings are possible
    exceptions.

46
  • Adequate head and facial hair coverings must be
    provided and properly used, and should not be
    kept in place with the aid of hairpins or other
    fastenings which could drop off.
  • All hair should be fully contained in the head
    covering.
  • Exposed cuts and abrasions must be covered by a
    waterproof dressing which should be metal
    detectable, brightly colored and easily seen
    against a background of product.

47
  • Smoking, eating and drinking and the use of
    chewing gum should be restricted to designated
    areas only, with adequate waste disposal and
    hand-washing facilities.
  • The training program should explain the necessity
    for the restrictions and disciplines required in
    production areas.

48
  • 3.9 Good requires clear instructions concerning
    the use and disposition of general materials to
    appear in Master Manufacturing Instructions,
    Plant Operating Instructions, Maintenance and
    Service Instructions and Cleaning Manuals.
  • It includes the general tidiness and cleanliness
    of production areas and covers infestation
    control.
  • Buildings must be protected against penetration
    by animals, birds, rodents and insects.

49
  • Secondary defences such as poisoned baits, flying
    insect electrocutors, sticky boards and sprays
    should be used in appropriate areas to deal with
    animals and insects which do penetrate the
    building.
  • Due care should be taken to ensure that these
    controls in themselves do not prove a means of
    food contamination.
  • Wood, glass and paint should, where practicable,
    be eliminated from open food areas and plant.

50
  • Metal/ Foreign Body Detection
  • 3.10 Processing should be designed to include
    procedures which will minimize the risk of
    foreign body contamination of the product.
  • Containers may be kept inverted where
    practicable, and should be cleaned by jets of
    filtered air or potable water before being
    filled.
  • Techniques such as sieving, sifting, washing, air
    and liquid flotation, magnetic grids and plates,
    electronic color sorting and visual inspection
    and sorting should be used as appropriate.

51
  • Effective metal detectors should be employed on
    the plant at suitable points in the process.
  • More elaborate methods, such as X-ray
    examination, exist and may be useful.
  • In addition to the use of X-ray examination in
    factories, cargoes in containers or road vehicles
    may be X-rayed at some ports during
    import/export.
  • Where metal detectors are used within the process
    they should always include automatic rejection
    systems and closed containers to hold reject
    materials.

52
  • Detection of foreign matter may lead to material
    which can in some instances be reprocessed.
  • 5.11 A formal risk assessment should be
    undertaken to determine whether foreign body
    detection equipment should be used within the
    manufacturing process to detect foreign body
    contamination.
  • 5.12 Methods of foreign body control should be
    defined in formal procedures. These should
    include instructions for undertaking the
    procedure and actions to be taken in the event
    that monitoring identifies product and/or
    equipment failure.

53
  • These procedures should address the action to be
    taken to identify the product which may be
    affected, its location, recall back to the
    production unit and the protocol for
    re-inspection.
  • All materials and/or products should be
    re-inspected that have passed through the
    inspection method or detection equipment since
    the procedure was last known to be fully
    operational i.e. working correctly.

54
  • 5.13 Consideration should also be given to
  • the food being analysed especially particle
    size and the packaging type (if detection is
    undertaken following packing)
  • the type of detector required
  • the degree of sensitivity required
  • where the detector is to be positioned on the
    process line
  • the mechanism for rejection following failure
    (reject arm, locked box system, automatic line
    stop).

55
  • Rejection procedures should be formalised and
    only authorised personnel should be able to
    access the locked box or product which has been
    rejected by the foreign body detector
  • the method of detector calibration (either
    manual or automatic)
  • formal procedures, which define equipment
    start-up and operating instructions, and the
    routine monitoring, testing and calibration of
    detector equipment, including metal detectors
    and

56
  • reporting of incidents and implementation of
    effective, timely corrective action.
  • The incident and the corrective action taken
    should be recorded in the event of a failure of
    the foreign body detector.
  • This will include stopping the process, and the
    subsequent isolating, quarantining and
    reinspection of all items produced since the last
    acceptable test result.

57
  • 5.14 Where recycled glass containers are used,
    provision should be made for the inclusion of
    automated vision inspection systems to inspect
    the containers for damage and contamination,
    including cleaning residues.
  • 5.15 The delivery or storage of materials may
    involve intermediate packaging to prevent damage.
    This will subsequently have to be
  • removed. This should be designed to minimize
    the risk of its contaminating the product during
    its removal.

58
  • Packaging should be clean prior to removal of
    contents.
  • Materials packed in sealed (seamed) metal
    containers have the obvious hazard of metal swarf
    being created when they are opened.
  • Cartons should be staple free paper sacks
    easy-open, string free and not cut with blunt
    knives.
  • Plant operatives should be trained to open
    packaging carefully to avoid product
    contamination, for example by the misuse of
    case-opening knives.

59
  • The use of a de-boxing/de-bagging area with the
    transfer of ingredients into internal packaging/
    containers before being transferred to the
  • processing area is recommended to minimize
    the potential for foreign body contamination.
  • Knife control procedures should be implemented.
  • 5.16 All final packaging used by the manufacturer
    for products should be examined to ensure
    compliance with the specification against which
    it is purchased.

60
  • In addition to this examination, detailed
    appraisal of a manufacturing scale sample, such
    as a pallet load on a production line is strongly
    recommended.
  • This allows the performance of a high risk
    packaging material such as glass to be better
    assessed before acceptance of the bulk delivery
    for use.
  • In order to implement this protocol effective lot
    traceability of packaging material is required.
  • Packaging materials should be brought to their
    points of usage in minimal quantities.

61
  • 5.19 Regrettably, contamination of products by
    foreign bodies may on occasion be caused
    deliberately
  • (a) during production by an unstable, malicious
    or disgruntled person
  • (b) somewhere in the distribution /retailing
    chain, by an individual seeking to harm or
    blackmail a company or
  • (c) after purchase, by an individual seeking
    financial gain or publicity.
  • While it is difficult to establish complete
    safeguards against case
  • (a), it is less likely where good industrial
    relations are fostered.

62
  • In addition, management should carefully weigh
    the dangers of allowing particular persons under
    notice of dismissal or redundancy to work out the
    period of their notice.
  • Case (b) hazards should be minimised wherever
    practicable by the use of tamper-evident
    packaging.
  • As regards (c), careful study of the relevant
    facts and laboratory examination of the foreign
    body should be carried out, the results of which
    may sometimes demonstrate the probability (or
    even certainty) that it had been introduced
    subsequent to the pack having been opened.
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