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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

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

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

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.

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.

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.

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

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,

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

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.

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.

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.

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.

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

(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

(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

(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.

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.

(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).

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

(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.

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

(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

(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

(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

(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

(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.

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.

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.

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.

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.

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

(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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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

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.

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.

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.

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.

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.

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.

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.