Transcript دــيجلا عينصتلا ةسرامم ذغلا عينصتلا يف يئا Food and Drink Good Manufacturing Practice

‫ممارسة التصنيع الجيــد في التصنيع الغذائي‬
‫إعداد‬
‫الدكتور علي كامل الساعد‬
‫قسم التغذية والتصنيع الغذائي‬
‫كلية الزراعة‪/‬الجامعة األردنية‬
‫‪email :[email protected]‬‬
‫‪Food and Drink Good Manufacturing Practice‬‬
‫‪1‬‬
GMP 5
Food and Drink Good Manufacturing Practice
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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.
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CONTENTS
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Acknowledgements
Prefaces
Decision Makers Summary
Part I General Guidance
Chapter 1 Introduction
2 Quality Management System
3 Hazard Analysis Critical
Control Point (HACCP)
4 Food Allergens
5 Foreign Body Controls
6 Manufacturing Activities
7 Management Review and
Internal Audit
Page
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ix
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8 Product and Process Development and Validation
9 Documentation
10 Product Identification and Traceability
11 Personnel and Training
12 Premises and Equipment
13 Water Supply
14 Cleaning and Sanitation
15 Infestation Control
16 Purchasing
17 Packaging Materials
18 Internal Storage
19 Crisis Management: Complaints and Product
Recall
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20 Corrective Action
21 Reworking Product
22 Waste Management
23 Warehousing, Transport and Distribution
24 Contract Manufacture
25 Calibration
26 Product Control, Testing and Inspection
27 Labelling
28 Electronic Data Processing and Control Systems
29 Good Control Laboratory Practice
and Use of Outside Laboratory Services
30 Environmental Issues
31 Health & Safety Issues
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141
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Part II Supplementary Guidance
on Some Specific Production Categories
Chapter 32 Heat Preserved Foods
33 Chilled Foods
34 Frozen Foods
35 Dry Products and Materials
36 Compositionally-preserved Foods
37 Foods Critically Dependent on Specific
Ingredients
38 Irradiated Foods
39 Novel Foods and Processes
40 Foods for Catering and Vending Operations
41 The Use of Food Additives and Processing Aids
42 Responsibilities of Importers
43 Export
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Food & Drink - Good Manufacturing Practice: A Guide
to its Responsible Management
PART I – GENERAL GUIDANCE
1. 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.
7
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.
8
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.
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‫دعامتي التصنيع الجيد‬
‫ممارسة التصنيع الجيد‬
‫ضبط األغذية‬
‫ضبط الجودة‬
‫تأكيد الجودة‬
‫‪10‬‬
‫التصنيع الفعال‬
‫العناوين األخرى ذات األهمية التي تشملها ممارسة‬
‫التصنيع الجيد بناءا على اإلصدار الرابع‬
‫ممارسة التصنيع الجيد‬
‫‪11‬‬
‫التصنيع الفعال‬
‫ادارة الجودة‬
‫المباني واألجهزة‬
‫التصنيع‬
‫التوثيق‬
‫العاملين والتدريب‬
‫إعادة الشغل أو التصنيع‬
‫الشكاوي واالستدعاء‬
‫الضبط الفعال‬
‫ممارسة المختبر الجيد‬
‫التعليب‬
‫األغذية الجافة‬
‫المواد الخام‬
‫خدمة الطعام‬
‫التبريد‬
‫األغذية المشععة‬
‫بطاقة البيان‬
‫االجسام الغريبة‬
‫التجميد‬
‫األغذية الخاصة‬
‫التخزين‬
‫المواد المضافة‬
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.
12
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.
13
• 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.
14
• 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:
15
• 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,
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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;
17
• 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.
18
Good Manufacturing Practice
2.3 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.
19
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 9000:2008 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.
20
• Quality management system standards have been
developed specifically for food manufacturing
especially with increasing globalization of food
production.
• These include BS EN ISO 22000:2005 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.
21
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;
22
• (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;
23
• (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;
24
• (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.
25
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.
26
• (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).
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• 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;
28
• (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.
29
• 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;
30
• (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;
31
• (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;
32
• (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;
33
• (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;
34
• (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..
35
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.
36
• 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.
37
• 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.
38
• 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.
39
• 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.
40
• 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 humanorigin foreign bodies.
• 3.3 Internal sources of foreign bodies
include the following:• (i) the building and installations;
41
• (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.
42
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.
43
• 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.
44
• 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 nondetachable 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.
45
• 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.
46
• 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.
47
• 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.
48
• 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.
49
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.
50
• 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.
51
• 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.
52
• 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 reinspected that have passed through the inspection
method or detection equipment since the
procedure was last known to be fully operational
i.e. working correctly.
53
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).
54
• 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 startup and operating instructions, and the routine
monitoring, testing and calibration of detector
equipment, including metal detectors; and
55
• 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.
56
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.
57
• 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 easyopen, 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.
58
• 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.
59
• 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.
60
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.
61
• 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.
62