FS /1/ 003

Issue 01
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GMP - MANUAL

Prepared By: -----------------

Tanveer Ahmad (MQA)

Supported By: -----------------

Abdul Gaffar Katiya

Reviewed By: -----------------

MR / GDM-CFL

Approved By: -----------------------

Deputy Managing Director

Coronet Foods Pvt Limited.

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 General GMP Requirements for Coronet Foods Pvt. Limited.

1. INTRODUCTION ............................................................................................................................................. 4
1.1 SCOPE............................................................................................................................................................... 4
1.2 DEFINITIONS ..................................................................................................................................................... 4
1.3 HOW TO MEET THE POLICY................................................................................................................................ 5
1.4 COMPONENTS OF A CORONET FOODS QUALITY ASSURANCE SYSTEM ...................................................................6
1.5 LEGALVERSUS CFL RREQUIREMENTS............................................................................................................... 6
1.6 STRUCTURE OF THIS DOCUMENT ....................................................................................................................... 6
1.7 THE PRINCIPLES OF IDENTIFYING AND CONTROLLING HAZARDS AND/O RQUALITY DEFECTS.............................. 6
1.8 HYGIENIC MANUFACTURING AREAS AND HIGH CARE AREAS ............................................................................. 7
1.9 FOOD SECURITY ............................................................................................................................................... 7
2. FACTORY DESIGN AND LAYOUT .............................................................................................................. 8
2.1 CIVILENGINEERING ........................................................................................................................................... 8
2.1.1 The Site ................................................................................................................................................... 8
2.1.2 Buildings and facilities ........................................................................................................................... 8
2.1.3 The manufacturing area .......................................................................................................................... 9
2.1.4 Laboratory and testing facilities ............................................................................................................. 9
2.1.5 Sanitary facilities, changing facilities and toilets .................................................................................... 9
2.2 UTILITIES ............................................................................................................................................................................................. 10
2.2.1 Layout ................................................................................................................................................... 10
2.2.2 Lighting ................................................................................................................................................. 10
2.2.3 Ventilation, climate control and compressed air................................................................................... 10
2.2.4 Water..................................................................................................................................................... 10
2.2.5 Re-use of water ..................................................................................................................................... 10
2.2.6 Waste water........................................................................................................................................... 11
2.2.7 Facilities for storage of waste and inedible materials .......................................................................... 11
2.3 EQUIPMENT .................................................................................................................................................... 11
2.3.1 Design ................................................................................................................................................... 11
2.3.2 Materials used in equipment ................................................................................................................. 11
3. PRODUCT DESIGN AND SPECIFICATIONS. .......................................................................................... 12
3.1 QA REQUIREMENTS IN INNOVATION ............................................................................................................... 12
3.2 HAZARD ANALYSIS CRITICALCONTROLPOINT(HACCP)................................................................................ 12
3.3 INNOVATION PROCESS MANAGEMENT(IPM) .................................................................................................. 13
3.3.1. Ideas/ Feasibility / Capability ............................................................................................................... 13
3.3.1 Launch preparation phase..................................................................................................................... 14
3.3.2. Post launch evaluation phase ................................................................................................................ 14
4. RAW AND PACKAGING MATERIALS ..................................................................................................... 15
4.1. SELECTION AN DMANAGEMENT OF SUPPLIERS .............................................................................................. 15
4.2. SPECIFICATIONS AND APPROVAL.................................................................................................................... 16
4.3. RECEIVING, CHECKING AND STORAGE OF RAW-AND PACKAGING MATERIALS....................................................16
4.4. WATER, STEAM AND ICE .......................................................................................................................................17
4.5. PACKAGING MATERIALS ................................................................................................................................ 17
5. PROCESSING AND PACKAGING OPERATIONS ................................................................................... 18
5.1. PROCESS DESIGN AN DHACCP ...................................................................................................................... 18
5.2. AREA SEGREGATION ...................................................................................................................................... 18
5.3. PROCESS CONTROL, QUALITY RECORDS AND CALIBRATION ...............................................................................19
5.4. CONTROL OF FOREIGN BODIES ....................................................................................................................... 19
5.5. MANAGEMENT OF CHANGE ........................................................................................................................... 19
5.6. NON-CONFORMING PRODUCTS AND MATERIALS ............................................................................................ 20
5.7. REWORK ........................................................................................................................................................ 20
5.8. CODING AND TRACEABILITY TO MATERIALS ................................................................................................. 20
5.9. MAINTENANCE AND ENGINEERING ................................................................................................................ 20

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6. FINISHED PRODUCT ................................................................................................................................... 22
6.1. SPECIFICATIONS ....................................................................................................................................................22
6.2. SHELFLIFE .............................................................................................................................................................22
6.3. VERIFICATION OF CONFORMITY TO SPECIFICATION ....................................................................................... 22
6.4. CONSUMER FEEDBACK ..........................................................................................................................................23
6.5. CONSUMER INFORMATION AND PROMOTIONS................................................................................................. 23
7. STORAGE, TRANSPORTAND DISTRIBUTION ....................................................................................... 24
7.1. GENERAL....................................................................................................................................................... 24
7.2. TRACEABILITY TO CONSUMERS OR CUSTOMERS ............................................................................................. 24
7.3. TRANSPORTATION ......................................................................................................................................... 25
7.4. STORAGE ....................................................................................................................................................... 25
8. HYGIENE, CLEANING AND PESTCONTROL ......................................................................................... 26
8.1. GENERAL....................................................................................................................................................... 26
8.2. CLEANING & DISINFECTION PRINCIPLES ....................................................................................................... 26
8.3. CLEANING ..................................................................................................................................................... 26
8.4 DISINFECTION................................................................................................................................................ 27
8.5 CLEANING OUT OF PLACE(COP).................................................................................................................... 27
8.6. PEST CONTROL.............................................................................................................................................. 27
9. PERSONNEL & TRAINING ......................................................................................................................... 29
9.1 TRAINING STANDARDS ................................................................................................................................... 29
9.2 COMMUNICABLE DISEASES, INJURIES & HEALTH SCREENING .......................................................................... 29
9.3 SANITARY AND PERSONAL HYGIENE PROCEDURES ......................................................................................... 29
9.4 STAFF CATERING SERVICES ............................................................................................................................. 30
APPENDIX 1. PREVENTION OF GLASS FOREIGN BODY HAZARDS ....................................................... 31
1. INTRODUCTION.................................................................................................................................................... 31
2. GENERICREQUIREMENTS ..................................................................................................................................... 31
3. PREVENTIONOF GLASS CONTAMINATION OFPRODUCTSFROMGLASS CONTAINERS................................................. 32
APPENDIX 2. ABBREVIATIONS ......................................................................................................................... 34

APPENDIX3. REFERENCE LIST ......................................................................................................................... 35

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1. Introduction

Rationale

This document has been written to provide specific guidance to Coronet Foods (CFL) operations on
general food hygiene, as a basis to be used to get here with additional product specific measures laid
down in Good Manufacturing Practices, to control food hazards and quality.

Objective

To be able to consistently produce safe and wholesome products of good quality that, in line with our
Corporate Purpose, meet the everyday needs of people everywhere, every Biscuit process within
Coronet Foods must have a set of generic measures in place.

On top of these generic measures, product specific measures are taken based on a good design process,
hazard analysis and risk evaluation to ensure consistent delivery of safe and good quality Biscuit
products meeting consumer expectations.

These General GMP Requirements have been written:

To clearly formulate the minimum standards for Coronet Foods Pvt Limited, to producing Biscuit
products
To explain the Coronet Foods approach to Quality Assurance
To focus owning safe by design and right first time based on Codex Alimentarius, Hygiene
guidelines and ISO principles

1.1 Scope
1.2
This document deals with Biscuit safety and quality in Coronet Foods Manufacturing Unit of English
Biscuits Manufacturers Private Limited, Pakistan and includes guidance for transport and distribution, but
does not cover agricultural practices. This document describes two elements of a Coronet Foods QA system,
the General GMP Requirements and the basics of hazard analysis and control.

1.3 Definitions

Batch: Amount of dough produced at one time from one set of materials under the
same conditions.

Cleaning: The removal of soil, food residues, dirt, grease or other objectionable
foreign matters

Contaminant: Any biological or chemical agent, foreign matter, or other substance not
intentionally added to Biscuit dough which may compromise Biscuits safety
or quality.

Disinfection: Also called sanitation, is the reduction, by means of chemical agents and/or physical
methods, of the number of micro-organisms in the environment, to level that does
not compromise Biscuits safety or quality.

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Food handler: Any person who directly handles and may contaminate packaged or un-packaged
Biscuits (Food), equipment and utensils, or food contact surfaces and is therefore
expected to comply with food (Biscuits) hygiene requirements.

Food hygiene: All conditions and measures necessary to ensure the safety and quality of Biscuits at
all stages of the supply chain.

Food security: A set of appropriate measures taken to minimize the risk of food being
subjected to tampering or criminal or terrorist action in the supply chain.

HACCP: Hazard Analysis Critical Control Point, a system that identifies, evaluates, and
controls hazards which are significant for food safety.

Hazard: A (micro) biological, chemical or physical agent in, or condition of, food with
the potential to cause an adverse health effect.

High-care area: A physically segregated area, designed to a high standard of hygiene (Recipe
room, mixing and crumb section), where practices relating to personnel,
materials, equipment and the environment aim to prevent product
contamination by pathogenic micro-organisms.

Hygienic An area where food can be prepared with a minimum risk of contamination
Manufacturing and process controls can be operated effectively area

Lot: An amount of food or materials having the same code.

Must: A practice that is mandatory for Coronet Foods operations

Risk: A function of the probability of an adverse health effect and the severity of
that effect, consequential to hazard(s) in Biscuits.

Should: A recommended practice that may become mandatory for all operations in the future
and that is compulsory in new investments.

Supply Chain: All stages of the production of Biscuit from primary production up and until final
consumption by the consumer (also called food chain).

Trade unit: The unit sold, holding one or more customer or consumer units that is coded to allow
traceability back to the manufacturing process.

CFL: Coronet Foods Private Limited

1.4 How to meet the Food Safety policy

To be able to meet this policy, Coronet Foods have the capabilities and systems in place which address
product safety and quality along the entire" supply chain", from pre-processing, production, packaging,
storage, distribution and sales to the use by the customer and/or consumer. The systems must focus on
Biscuits quality and safety by design.

1.5 Components of Coronet Foods Quality Assurance system

The emphasis must be on prevention rather than detection, through the design of safe products, processes
and infrastructures. Employees must be properly trained to ensure they understand and can implement the
operations and procedures. The mandatory elements of Coronet Foods Quality Assurance system are
implementation of:

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 Specific Standards
Materials, Product & Specific Food safety standards and specifications
General GMP Requirements for Biscuit Manufacturing
A set of basic physical and organizational measures which apply to Biscuit Manufacturing in general,
described in this document.
Hazard Analysis and Critical Control Point (HACCP)
Good Manufacturing Practices Which mandate product category specific policies and procedures
provide input for developing best practices. CFL must regularly verify implementation and
effectiveness of their Quality Assurance systems through internal audits of all sections (Processes,
storage, warehouse)

1.6 Legal versus Coronet Foods requirements

In many countries, legal regulations are in place covering almost all chapters and elements of these
requirements. It is our responsibility to ensure compliance in the event that countries have stricter
regulations than described here, local legislation will take precedence over our requirements.

1.7 Structure of this document

This document is based on the Codex Alimentarius Food Hygiene Basic Texts"(Alinorm97/13A),
collection of internationally adopted food standards. The text has been rearranged and specific requirements
for Coronet Foods have been added, for example the requirement on supplier approval. This document
provides the basic mandatory requirements and is also the base line standard for all auditing of CFL
operations manufacturing Biscuit products. It there for eases the word" must" to identify mandatory
elements, should is used to describe a practice that must be in place in newly built operations and may
become a must in the future where the availability of documentation is mandated. For documentation
and management systems the ISO format is recommended which are implemented across the Coronet Foods
Manufacturing site.

1.8 The principles of identifying and controlling hazards and/or quality defects

A key step in the design of a quality assurance system is the identification; evaluation and control of hazards
/or quality defects. There are three elements:

1. Hazard (or Quality defect) Analysis

Identification of possible hazards or quality defects for Biscuit safety, these can be chemical, physical
(foreign bodies), microbiological and allergen hazards.

2. Risk evaluation

An evaluation of the likelihood that a hazard or quality defect will actually occur, in combination with
an assessment of the severity of the effect, this is normally based on scientific data, historical data; the
characteristics of processes used in the supply chain and anticipated consumer use. It is a part of
HACCP (Codex Alimentarius), and is also used for instance to evaluate supplier related material risks
(Coronet Foods Supplier Management Manual)

3. Controlling hazards or defects

If through the hazard analysis and risk evaluation a potential realistic hazard and/or relevant potential
quality defect is identified, an effective control system must be implemented. Measures can be taken in the
whole supply chain, like setting critical limits in raw material specifications, setting critical process
parameters in the manufacturing process, defining storage and transport conditions or \ formulating on-

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pack user information.

In food operations Hazard Analysis Critical Control Point must be used to systematically approach safety
hazards and implement the related controls. A systematic way to assess the relevance of quality defects
from consumer point of view is the Rainbow program from which required control points or improvement
programs can be identified. Risk evaluation should indicate the chances of a hazard or quality defect
occurring in an individual material supplier and lead to for instance specification changes, adaptation of a
process, implementation of a monitoring program or determination of an audit frequency.

1.9 Hygienic manufacturing areas and high care areas

In a Biscuit Manufacturing environment an appropriate level of hygiene is a standard requirement, but

when a HACCP study identifies a high risk of contamination from the environment or from one process
to another, leading to a realistic risk to the consumer, additional hygiene measures may be required in
specific areas. These areas are called high care (or ultra clean) areas and must be effectively separated
from the normal hygienic manufacturing areas to prevent cross-contamination. This area segregation is
mostly applied to control microbiological hazards in sensitive products, where contamination will not be
controlled by further processing steps. High care areas will typically be used where open product is
handled; Where contamination is unlikely to happen. CFL declares Recipe room, Sugar, flour sifting,
Mixing, cream section, cold rooms & crumb section as High Care Areas.

1.10 Food Security

The terrorist actions particularly in the U.S.in 2001 have highlighted the necessity for appropriate measures
on Food Security, to minimize the risk of tampering or terrorist action in each segment of the Foods Supply
chain. Organizations should determine what level of security they require in the context of their local
situation. Good guidance can be found on the FDA website, CFL actions declares as mandatory steps.

Thoroughly screening of permanent and workers at the time of entrance

All CFL employees must follow the Personal hygiene and GMP Principles
Visitors will be allowed after thorough security investigation and Visitors form will be followed
3RD Party working must be followed the security and food safety instructions as mentioned in
Visitors form.
All floor cleaning chemicals and Pest sprays must be placed in lock and key, its daily issuance must
be done under security officer
3rd party maintenance, civil work or paint work will not done during production
All vehicles must be screened thoroughly at gate.
Meals and drinks must be avoided to serve in production facilities.

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2. Factory design and layout

Objectives:

To have premises, equipment and facilities located, designed and constructed so that:

Effective operation, control, cleaning, disinfecting and maintenance is enabled to minimize the
risk of product contamination
Hazards are contained by process control, segregation or separation where appropriate
There is a logical flow of people and materials so that cross-flow is minimized
Temperature, humidity and lighting can be controlled where necessary for the product and/or
process
Adequate facilities are provided, properly maintained and segregated from production areas for
cleaning of equipment and to enable an adequate level of personal hygiene
Pest access and infestation is minimized

2.1 Civil Engineering

2.1.1 The Site

Establishments should be located in areas, which are substantially free from objection able odors,
smoke, dust or other environmental contaminants and which are not subject to flooding.
Roadways and areas within the boundaries of the CFL or in its immediate vicinity must have a hard
surface suitable for wheeled traffic and adequate drainage to minimize dust generation and to keep
roadways and areas clean and tidy.
The site layout and fencing must allow control of access of personnel and material sat an adequate
level of security.

2.1.2 Buildings and facilities

Buildings and facilities should be soundly built of non-toxic materials and easy to maintain and clean
Manufacturing and storage areas, changing rooms, showers and toilets rooms should be designed to
stay free from condensation, vapor and standing water.
Adequate working space must be provided to permit the satisfactory performance of all equipment
and operations.
Design of building and facilities must permit easy and adequate cleaning and minimize the entrance
and harboring of pests and the entry of environmental contaminants such as smoke and dust.
Areas for delivery of materials and products must allow efficient loading and unloading, prevent
product contamination and ensure that products and materials can be kept under their required storage
conditions.
General areas and social facilities (e.g. entrance lobbies, reception areas, canteens, restrooms,
changing areas) should be separate from and not open directly to, dough or Biscuit handling areas
and must be kept clean.
In the layout, a logical flow of people and a minimal cross flow of materials must be taken into
account, to prevent cross contamination. Area segregation must be provided where necessitated by the
outcome of the hazard analysis and risk evaluation.

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2.1.3 The manufacturing area
Construction materials used in side manufacturing areas must be non-toxic, non-flaking, resistant to
the (cleaning) chemicals used, capable of being easily cleaned and not be water-absorbent. Materials
should have a light color showing dirt easily, wood should not be used.
Horizontal surfaces, for instance windowsills should be avoided to reduce dust accumulation and prevent
use of these surfaces for storage of materials, which could lead to foreign body contamination.
Floors must be non-slip and where relevant should slope sufficiently for liquids to drain to trapped
outlets protected by grilles that should be made of stain les steel.
Where floor drains are installed they must be designed and maintained to prevent blockage and to be
capable of coping with the peak capacity of water. They must also be cleanable and properly trapped.
Floor drains should not be positioned directly below or above equipment handling open product.
Drainage should be from clean to dirty areas.
Walls must be smooth and without crevices up to a height appropriate for the particular operation.
They should be of a suitable color that shows up dirt and they must be easy to clean and disinfect.
Ceilings, must be so designed, constructed and finished to minimize flaking, the accumulation of dirt
and condensation. False ceilings must allow for inspection and easy cleaning.
Windows and other openings must be built to prevent accumulation of dirt. Windows which open
must be fitted with screens to prevent access by insects. Screens must be easily removable for
cleaning and kept in good repair. Windows must be break proof or protected, if shattering can
introduce a glass hazard to products.
Doors must have smooth, non-absorbent surfaces, and must be easy to clean and disinfect. Doors
should be self-closing and should not directly open to outside areas, with the exception of safety doors,
which should only be opened in case of an emergency.
Structures like stairs; pipe bridges, services and fittings must be installed in such a way that product
contamination by leaks accumulated dirt or condense is prevented, particularly over open product. All
constructions must be easy to clean.

2.1.4 Laboratory and testing facilities

Laboratories must be installed in separate rooms of adequate space for reasons of hygiene, safety and
security and must not open directly on to the production hall, if there is any risk of contamination.
Measures must be particularly taken to prevent contamination from the microbiological laboratory to
other areas, for instance through ventilation.
Walls, floors and ceilings should meet the requirements for the typical work conditions and be
maintained accordingly.
Testing facilities for measurements directly at production lines must be set up such that controls can
be performed adequately without risks for ongoing production or product.
All testing equipment must be designed to withstand or be protected appropriately against potential
relevant extreme conditions such as heat, dust, moisture, steam, odors, noise, vibration and other
disturbances that can interfere with the accuracy of the analytical tests or introduce a risk to product or
personnel.

2.1.5 Sanitary facilities, changing facilities and toilets

Adequate, suitable and conveniently located changing facilities and toilets must be provided in all
CFL. Shower rooms must be provided where appropriate or required by law.
For personnel working with unprotected product there must be means for storing outdoor clothes and
shoes, physically separated from areas used for storing work clothes, when this otherwise would lead
to a realistic cross contamination hazard.
The facilities must be well lit, ventilated and where appropriate cooled as per Biscuits requirements
and should not open directly on to food handling areas. Hand washing facilities with running water
and soap, Liquid soap, hand sanitizer and with hygienic means of drying hands must be provided.
Non-hand operable taps are recommended.

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 2.2 Utilities

2.2.1 Layout
Services, pipes and ducts should drop vertically from the ceiling to the equipment.

2.2.2 Lighting
Adequate natural or artificial lighting must be provided to enable personnel to operate in a hygienic
and safe manner and where relevant facilitate specific processes like sorting, packing, crumb opening,
inspection
Lighting in all production and storage areas must be equipped with an appropriate cover to catch glass
fragments in case of lamp breakage.

2.2.3 Ventilation, climate control and compressed air

Adequate ventilation must be provided to remove excessive heat, steam, dust and to dry the area in an
adequate time after wet or dry cleaning. The direction of the air flow must be from clean todirty
areas, when this otherwise would lead to a realistic contamination risk.
Ventilation ducts must be accessible for inspection and cleaning. Openings must be provided with a
screen of suitable mesh size to prevent the entry of pests. Screens must be easily removable and easy
to clean.
Where climate conditions like temperature or humidity are critical for product /or material safety a
control system must be in place. Climate control must be designed to cope with extremes of local
conditions and must be equipped with measuring devices for monitoring. An alarm system indicating
gloss of control should be in place.
Where compressed air is used in possible contact with Biscuit it must be treated to prevent
contamination of the Biscuits. If lubricants are used for the compressors, oil filters must be used and
the lubricants must be toxicologically approved.

2.2.4 Water
There must be an adequate supply of potable water, which must be used whenever necessary to
ensure Dough/ Biscuit stuffs is not contaminated. Potable water must conform to WHO guidelines
for Drinking Water
Where non-potable water is used, for example for fire control, steam production, refrigeration or other
similar purposes, it must circulate in a separate system and be identified as such. Non-potable water
must not connect with, or allow refluxing to, potable water systems.
In situations where utility water comes into contact with product deliberately or accidentally, it must be
ensure that the use of this water does not introduce a hazard to health or is likely to contaminate the
Biscuits. A thorough hazard analysis and risk evaluation must be carried out to ensure all hazards are
identified and appropriate procedures/controls put in to place. In those cases the utility water should be
potable water; single used only, or preserved water from a potable source.

2.2.5 Re-use of water

Re-circulated water and water recovered from washing or processing of Biscuits maybe used for
agriculture purposes, either with or without further treatment, a treatment process, if used, must be
effective and monitored. Re-circulated water must have a separate distribution system that can be easily
identified.

2.2.6 Waste water

CFL must have efficient drainage and waste disposal systems, which must be maintained in good
condition and meet legal requirements. All drainage lines must be large enough to carry peak loads
and must be constructed to prevent contamination of Biscuit materials or potable water supplies.
Waste water from refrigeration plant, hand and equipment wash facilities, should be ducted to the
drains to prevent any possibility of product contamination.

2.2.7 Facilities for storage of waste and inedible materials

Storage areas for waste and in edible material must have a hard surface; adequate drainage and
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 provisions to keep the area clean and tidy. There should be dedicated areas for waste containers.
The facilities must be designed to prevent contamination of the rest of the premises as well as access
by pests. They should be enclosed and covered.

2.3 Equipment

2.3.1 Design
Equipment must be designed to prevent product contamination and facilitate adequate cleaning in line
with the requirements of both process and product.
Equipment installation and lay out should permit adequate cleaning and disinfecting where
appropriate.
Equipment and pipe lines should be self-draining and easily to clean.
Equipment must be designed to prevent product contamination by processing aids (lubricants,
gearbox oil etc.)
All product contact surfaces must be either easily accessible for cleaning and inspection or be cleaned
by a procedure which has prevents or remove food debris and eliminate contamination.
Equipment must be constructed to minimize product hold-up e.g. in dead ends, where product can
accumulate and pose a safety or spoilage risk. Where dead ends cannot be prevented, the position and
dimension must be such that the cleanup of the line is maintained.
The line layout or applying roper insulation or drip trays should prevent condensation and possible
resulting product contamination
Equipment must be designed to minimize the risk of foreign body contamination by loose parts.

2.3.2 Materials used in equipment

Food contact materials must be approved for toxicological safety.
Equipment materials must be resistant to the product, cleaning agents and disinfectants under the
specified conditions for use.
Equipment surfaces must be smooth, without crevices and easy to clean and disinfect.
For guidelines see: European Hygienic Equipment Design Group (EHEDG) or ISO 14159
(Hygienic Requirements for the Design of Machinery.).

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3. Product Design and Specifications

Objectives

To design products and processes, which are safe, meet the customer and consumers
expectations and deliver consistent performance throughout the product shelf life.

Procedures are in place to ensure that parameters critical to maintain product safety
quality are identified, specified and controlled throughout the supply chain
Procedures are in place to transfer the responsibility from the design phase into the
supply chain
Any amendments made during the product design, trial or launch stage are risk
evaluated and corrective actions taken
The requirements of relevant product category specific GMPs are used in the design
process

3.1 QA requirements in Innovation

The emphasis of the Coronet foods Quality Assurance system must be on prevention rather than control
and correction. A safe design is the basis of reliable manufacturing of products that satisfy consumer and
customer expectations.
During the design phase, a hazard analysis and risk evaluation for both product and process must be
carried out to identify hazards and possible control measures, using HACCP.
Possible use by more sensitive sub-populations like children, the elderly, pregnant people or
individuals convalescing from illness must be taken into account in the risk evaluation
All risk evaluations must be approved in line with the Coronet foods, Food Safety Approval
Standard, See Reference 14..
The mandatory requirements of category specific GMPs must be used as a basis for product and
process development
Quality Assurance expertise must be used in the design process.
Design process must be a set of product, process and equipment specifications, to be used as the basis
for operational control in the actual production process.

3.2 Hazard Analysis Critical Control Point (HACCP)

HACCP is a systematic approach to identify, evaluate and control hazards that are significant for
consumer safety. It focuses on prevention rather than reliance on testing.
HACCP studies must be carried out covering the entire supply chain from primary production to final
consumption.
The application of this technique must start in the design phase and results in a design HACCP
containing Design Control Points, which must be used for guidance in the operational HACCP study
of the actual manufacturing process.
The intent of operational HACCP is to focus control on Critical Control Points. A Critical Control
Point (CCP) is a step at which control can be applied and is essential to prevent or eliminate a food
safety hazard or reduce it to an acceptable level.

HACCP elements
A HACCP study contains the following essential elements, as stated in Codex Alimentarius:
1. Conduct a hazard analysis

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2. Determine the Critical Control Points for all potential relevant hazards
3. Establish critical limits for all critical control points
4. Establish a system to monitor control of the CCP
5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not
under control
6. Establish procedures for verification to confirm that the HACCP system is working effectively
7. Establish documentation concerning all procedures and records appropriate to these principles and their
application.

The HACCP methodology can also be used to identify points critical for controlling quality
specifications. These are termed" Quality Control Points or QCP's.

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4. Raw and packaging materials

Objectives

Raw and packaging materials are managed to ensure product safety and quality is safeguarded and
materials meet specifications and legal requirements. This requires:

Sourcing of materials from approved suppliers only

Ensuring that materials are approved and have agreed specifications
Intake control based on risk evaluation and supplier performance
Ensuring that materials are stored under the right conditions
Meeting legal limits

4.1. Selection and Management of Suppliers

Suppliers must be approved before materials can be used for regular production, for:
All raw materials
All primary packaging materials
Other packaging materials in case of possible contamination of products or for strategic suppliers

Two types of risk must be evaluated to obtain approval:

1. Material risks
The specification owner must ensure a material risk evaluation is performed, assessing physical,
chemical, microbiological and quality related risks, independent of who will supply the material.
2. Supplier related risks
The supply manager must ensure that the supplier related risks are evaluated, taking into account:
Cross contamination with allergens or genetically modified material
Robustness of the suppliers quality management systems
The Coronet Foods Business principles Based on the outcome of the evaluation:
Suppliers of low risk materials can be approved based on information obtained through a
questionnaire. They must be approved through an audit in case there is in sufficient
information available.
All new potential suppliers of medium and high-risk materials must be audited by a trained and
competent auditor to obtain approval. This process must also be used for commodities and buying.
For high-risk materials, the auditor must have relevant specialist knowledge, or be accompanied
by a specialist.
Traders or brokers should not be used, as they often have no control over the supply chain and the
quality and safety of the materials. If they are used, a risk evaluation must be made taking into
account their quality management systems, followed by the normal approval process Based on the
audit rating, suppliers can be approved, conditionally approved, not approved or rejected.
In case suppliers have not obtained approval, they must not be used unless adequate measures have
been taken to secure the safety and quality of materials and to stimulate improvement.
Approvals must be reviewed regularly, preferably minimum every two years, based on supplier
performance, material risk and supplier risk. CFLmust have supplier management procedures in
place, which clarify

Roles and responsibilities,

Documentation of approved suppliers, audit results, trained auditors, evaluation results,
Corrective action records should be kept as well.

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4.2. Specifications and approval

All materials must be approved in line with the EBM R &D & Quality approval standard. Raw materials,
ingredients and packaging materials must be adequately specified as part of the contract with the supplier
and meet the specifications. Specifications and contracts must:
be formally agreed with and signed by the supplier and CFL
cover the potential relevant quality and safety targets and limits. This may include reference to CCP
sand QCPs
contain potential relevant requirements for storage conditions, batch coding, traceability and shelf life
specify potential relevant analytical methods, preferably ISO
contain reference to legal and Coronet Foods safety limits

4.3. Receiving, checking and storage of raw- and packaging materials

Raw material in take control should be based on an evaluation of the hazards and risks associated with
the material and the reliability of the supplier. This assessment should be done per material.
Rules and responsibilities for rejection should be clearly defined, e. g. because of pack damage or taint.
All materials must be registered and clearly labeled, indicating their nature and inspection status, so
that materials to be inspected or rejected materials are clearly distinguishable and separated from
approved materials (physically or via the material management system).
All materials must be stored according to the requirements included in the specification.
Supplier related quality data should be recorded to assess supplier performance and quality trends.
The shelf life of all raw materials must be specified and adhered to. Responsibility for extension of the
shelf life must be clearly specified and must only be done on case-by-case basis. First-in first out
(FIFO) must be applied to all materials.
Raw material containers must not be used for any purpose that may lead to contamination of the product,
for instance for the storage of non-food materials. Containers must be inspected immediately before use
to ensure that they are in a satisfactory condition and where necessary cleaned and /or disinfected.

4.4. Packaging materials

All packaging material must be stored in a manner that prevents unacceptable contamination. Storage
conditions should be such that the materials technical strength or machine ability is maintained.
Packaging materials must meet the requirements and the expected storage conditions of the final
product. Possible transfer of contaminants from secondary packaging to the food must be evaluated
and meet Coronet Foods and legal requirements. Packaging materials must provide adequate
protection from contamination and unacceptable loss of product quality during the products whole
shelf life.

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5. Processing and packaging operations

Objectives

To ensure processing and packaging operations are based on and meet product design requirements, as
laid down in product category GMPs and specifications resulting from the Innovation process.

This requires that:

The processes are under control and result in products conforming to specifications and
requirements.
A Hazard Analysis Critical Control Point (HACCP) study is implemented and validated for all
Processes involving food handling
A documented control system, work instructions and specifications with targets and critical limits
are implemented for critical quality and safety parameters. Operators have been trained to
understand and execute them properly.
All processes, maintenance, sampling and corrective actions are executed in such a way that
consumers and customers are protected.
Change processes are managed in a systematic way to ensure product quality and safety.

5.1. Process design and HACCP

Processing and packaging operations must be designed to produce food that is safe, conforms to legal
requirements and is of the required quality. An HACCP system must be implemented to ensure the safety
of the actual processes in the operation. For new products, the HACCP study must be based on the
information from the design process laid down in design control points (DCPs), specifications and on
product category GMPs.

5.2. Area segregation

If the necessity is indicated by the risk evaluation, HACCP and/or in GMPs, high care process areas with
specific hygienic standards must be implemented and physically segregated from other areas. Specific
measures should be based on the risk evaluation, and could be:
to change into dedicated clothing and/or foot wear at the interface between high care and normal
manufacturing areas
use colors or other codes to clearly identify clothing and equipment dedicated to high care areas
to mandate hand washing and disinfection at interface points
a controlled transfer of all materials and equipment into the high care area(e.g. by external
disinfection or removal of outer wrap before transfer)
to change of pallets from wood to plastic or aluminum in the interface
controlled climate conditions in high care areas(e.g. temperature, humidity, positive pressure by
means of filtered air)
to ensure effluent and air flows from high care to other areas and not the other way round, to prevent
contamination
to use dedicated portable and manual equipment in high risk areas

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5.3. Process control, quality records and calibration

A process control system must be implemented to include:

Work instructions and equipment manuals for all relevant process steps, including starting and
stopping as well as cleaning and maintenance instructions, in the appropriate language
the actual way a parameter is measured, recorded and monitored
the required frequency of measurements (continuous, once per shift etc.)
corrective actions either through procedures or software to keep processes within critical limits
procedures for corrective actions and disposal of product in actual out-of-spec situations
storage and analysis of process data
a table of personal responsibilities

Quality records and charts pertaining to inspection, testing, clearances and audits must be legible, dated,
signed or attributed for electronic records, stored and be easily retrievable. The storage period for documents
must be specified; at least exceeding the shelf life of the product involved and be in line with legal
requirements. In case an electronic system is used a backup must be available for critical documents and
procedures.
A system of internal auditing must be in place to verify HACCP / FSMS and the effectiveness of procedures
to ensure product safety and quality. Calibration of critical equipment must be carried out according to a
planned schedule, preferably against an external reference standard, at a frequency, which may be adjusted
on the basis of calibration results. A central record must be kept of all devices that are covered by the
calibration scheme. Actions must be taken to correct calibration deviations.

5.4. Control of foreign bodies

Hygienic design and operating practices and the application of HACCP / FSMS 22000/ FFSC 22000-2005
must prevent contamination with foreign bodies. The following measures should be used where relevant:
Ensuring proper control and procedures at suppliers
Regular inspection of incoming materials
Regular inspection and maintenance of the lines to limit damage to equipment and resulting
contamination
Ensuring that packaging of materials is opened in such a way that no loose fragments are created
Preventing broken glass in the manufacturing area
Use of (cleaning) tools, made of impervious material and of distinctly different color than the
processed foods, particularly for tools like brushes
A nut and bolt check list for equipment
Procedures for dismantling and assembly of equipment to ensure parts are not lost and possible
damage is reported
Metal detection, magnets and sieves
Covering lines where open product is transported

5.5. Management of Change

Management of change is a key process that must be form ally controlled and the responsibility for agreement
to changes must be clearly defined. For changes that could affect quality or safety the HACCP plans must
be reviewed for impact and updated if necessitated by the change. In case of fundamental changes of products
or processes the product design must be reconsidered.
5.6. Non-conforming products and materials

Employees must be trained to recognized efficiencies or deviations from specifications and to act on them
promptly. Non- conforming products or materials must be immediately blocked, clearly marked and
separated (physically or via an electronic material management system) from normal product or materials.
The responsibility for release of blocked product must be clearly defined and limited to authorized persons.
Clear procedures must be in place to prevent blocked product from beings enter out accidentally.

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5.7. Rework / Crumb Handling

Rework should be handled as an ingredient, if its use is permitted. Product recipes must indicate whether
rework may be included, of what type and at what percentage.
All rework operations must be considered in the operational HACCP plan and covered by a documented
procedure that describes:
What types of material can be reworked
What kind of pre-processing rework should receive, if any
How long rework materials can be stored and under what condition
How to maintain the lot tracking system
Where rework cannot be used due to allergen contamination

Collection of rework material in the production area should be done in clearly and distinctly marked (colored)
bin / Bags. These bins must be cleaned before entry into a high-risk area. Rework must be collected from the
processing areas as often as necessary, but at 4 hours basis daily.

5.8. Coding and traceability to materials

Each processing unit must contain best before information

Systems must be in place to be able to identify all lot so finished goods produced from a raw material lot
or process run. This can be based on material codes or the time window within which a material was used.
The size of one lot of finished product must be maximum one-day's production. Care must be taken to
maintain traceability and the first-in first-out principle in intermediate product storage or where rework
is used.

5.9. Maintenance and Engineering

In the application of equipment maintenance, TPM principles should be used. A permit to work system
should be in place to ensure maintenance and engineering work is carried out as a controlled process and
product quality and safety are not compromised. Facilities and equipment must be kept in an appropriate
state of repair and condition to:
Facilitate all cleaning and disinfection procedures
Function as intended to maintain parameters critical to product safety and quality
Prevent contamination of the food e.g. from rust, flaking paint or plaster or lubricants.
Minimize access from and harboring of pests
Maintenance or engineering work must be executed in such a way that risks to products are minimized, for
major processes this should be validated through a risk evaluation. If third party contractors perform
maintenance or engineering work, procedures must be in place to ensure they conform to hygiene
requirements and relevant product and process safety aspects. After maintenance or engineering work, an
inspection must be performed before start up to verify integrity of the lines, absence of foreign bodies and
conformance to the relevant hygiene requirements. All lubricants that may come into contact with raw
materials or open product must be food grade.

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6. Finished Product

Objectives

To consistently satisfy consumers and customers with good quality products, safe for their
intended use

Products have well defined specifications addressing all potential relevant safety and
Quality parameters
Products are safe and remain within specified minimum quality limits if kept under
realistic, specified conditions during their entire shelf life
Labeling gives consumers and customers clear and unambiguous instructions for safe
intended use of the product and enables them to make an informed choice
Consumer comments and complaints are centrally collected, evaluated and processed
and feedback given to consumer
Promotional items / information are formally approved by a competent person before
release

6.1. Specifications

For all finished products adequate specifications must be defined and recorded. Specifications must
Cover all relevant aspects throughout the supply chain. These should be:
Raw materials and packaging materials
Requirements for hygienic manufacturing, CCPs and QCPs
Reference to legal requirements (on key attributes, composition, consumer use and labeling, shelf life)
Distribution requirements
Product coding
Nutritional information and information with respect to health claims
Specific customer requirements
Specific CFL and/or local consumer requirements, for instance GMO labeling, allergens, halal.

Potential misuse in the supply chain and by consumers or customers must be considered when determining
finished product specifications and must be verified with actual product performance where relevant.

6.2. Shelf life

The actual shelf life period as declared must not be extended beyond the maximum safe shelf life period
as determined during the development process. Even if there is no safety risk, the shelf life should only be
extended when it has been thoroughly validated for all quality aspects.

6.3. Verification of conformity to specification

Regular checks must be performed during production to verify whether the actual product being produced
still conforms to its specifications. Reference samples must be taken regularly, clearly marked and stored
under the recommended conditions to be available in case of emergencies. Similarly held samples are to
be assessed at regular intervals to verify conformance to specification in time, unless so otherwise stated
in product category specific GMPs.

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Regular shop inspections should be performed to verify conformity to specification under market conditions
if there is no adequate consumer feedback. In out-of-spec cases, documented corrective actions need to be
taken and verified for effectiveness.

6.4. Consumer feedback

The packaging must contain legible contact details of the Marketing Sales selling the product, to enable
consumer feedback.
A central collection system must be in place within the Marketing/ Sales to record consumer complaints
and the response to the consumer. Complaints indicating product safety issues or serious quality failures
must be prioritized and sent to the manufacturing unit immediately. Consumer complaints must be followed
up with identification of causes and appropriate communications and corrective actions in the manufacturing
unit.
In addition, this data should be used as a basis for improvement processes and subjected to trend analysis,

6.5. Consumer information and promotions

All consumer communication containing information on product quality or safety and all promotional items
must be approved for any possible adverse health effects by a competent person or organization in line with
the Coronet Foods Consumer Safety Approval standard Storage and transport

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7. Storage, Transport and Distribution

Objectives

Storage and transport conditions of both raw and packaging materials, intermediate products,
technical materials and finished goods are controlled in line with the requirements of the
materials:

Procedures are in place to ensure that conditions, critical for product safety and
Quality are maintained and controlled.
Damage or mishandling, likely to result in a safety hazard or loss of quality is
prevented.
Procedures are in place and measures taken to prevent cross contamination between
materials and products, from the environment or from pests.
Lot coding and traceability is maintained.
Non- conforming products are clearly identified and physically separated from other
products.

7.1. General

During transport, storage and distribution:

Food must be adequately protected to prevent contamination by for instance pest infestation, cleaning
agents, dust or fumes.
Cross contamination, allergen-and odor transfer between Biscuits, Cream, raw materials and non-
food items must be prevented where it can affect food quality or safety, by using appropriate packaging
material and/or by physical separation.
Vehicles, silos and containers must be checked for hygiene, pests and possible (cross) contamination
prior to use where relevant.
Where storage and transport conditions are critical for product safety and/or quality they must be
controlled and monitored(e.g. temperature and temperature fluctuations, humidity, atmospheric
conditions, time)
Damage to the packaging resulting in spoilage or contamination must be prevented and stacking
heights should be controlled to prevent quality defects.
Where pallets are used, they should be in good condition, clean, free of taint and not cause damage to
the palletized goods.
Transport vehicles should be dedicated to food

7.2. Traceability to consumers or customers

It must determine to what level of detail they want to trace their products to consumers or customers and
implement systems to reach that level in line with the capabilities of the distribution system. As a
minimum, a detailed and up to date breakdown of the distribution system must be available to trace the
product flows, particularly relevant in case of a silent recall. This information requirement should form
part of the distribution or logistics contract.
7.3. Transportation

Transport vehicles and transport containers must be inspected before use to verify appropriate cleanliness
and absence of pests. Containers used for different purposes (transport of raw materials, rework, waste
collection etc.) must be distinctly marked to prevent cross contamination. Transport vehicles, conveyances
and containers must be easy to clean and where necessary disinfected prior to use. Transport vehicles for
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removal of waste from the site must be of appropriate cleanliness. Diesel (forklift) trucks must not be used
inside buildings, gas powered fork lift trucks may be used. Batteries for electrical fork lift trucks must be
charged in well-ventilated areas only.

7.4. Storage

Warehouses and distribution centers must be regularly inspected to ensure they meet the required storage
conditions. In warehouses and distribution centers, an adequate pest monitoring and control program
must be in place and regularly verified for effectiveness. All Biscuits product and materials must be
stored off the floor and sufficiently far away from walls to enable inspection, pest control and prevent
pest infestation. Containers used for storage must be clean to prevent contamination of stored materials.
Product and materials must be date marked and shelf life specified. A procedure for pallet location
must be in place to enable first in first out procedure, which must be followed to prevent use of out of
date product or materials and to ensure traceability.
Chemicals like cleaning agents, lubricants and pesticides, must be stored separately from food materials
in dedicated areas and/or containers and must be labeled with a warning about toxicity and proper use.
Chemical storage areas should be bonded. Hazardous substances must only be used by well-trained
personnel and Material Safety Data Sheets (MSDS) must be kept at the place of storage, which should
be locked to prevent misuse. Chemicals must not be stored in manufacturing areas unless in small
quantities necessary for production, preferably only in working concentration.
Trade returns should not be stored on manufacturing sites.
Waste must be stored in such a way that accesses by pests and contamination of food, potable water,
equipment, building so roadways on the premises is prevented. Waste containers must be distinctly
marked and regularly cleaned and should be covered.

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8. Hygiene, cleaning and pest control

Objectives:

To have validated cleaning and, where applicable, disinfection procedures in place to effectively
control food hazards, allergens, pests and other agents likely to contaminate food.

To design the manufacturing operation to allow adequate and effective cleaning in a

designated time.
Cleaning and disinfection procedures to be effective for the type of soil to be removed, the
properties of the process line and consumer use of the product
Cleaning procedures are documented in clear language and available for the operators Cleaning and
disinfection activities are validated and monitored and do not compromise Biscuit safety or quality
A pest control system is established Misuse of
chemicals is prevented

8.1. General

Cleaning and disinfection processes must be safe by design and therefore be included in the HACCP /
FSMS study or be part of an appropriate pre requisite program. Cleaning and disinfection effectiveness
must be validated and monitored.

8.2. Cleaning & Disinfection Principles

The purpose of cleaning is to remove soil, foreign matters (any undesired matter, including product
residues, whether or not containing micro-organisms and/ or allergens) to prevent contamination of the
product during subsequent production, but it will normally not remove all micro-organisms. For all
process equipment and general areas, documented cleaning, and where relevant disinfection procedures
must exist. These procedures must specify:
The frequency of cleaning and disinfection
The type and concentration of detergent and disinfectant to be used, the contact time and temperature
The level of dismantling of equipment (if applicable)
The method of cleaning
The method of monitoring cleaning effectiveness
Rinsing must be done if necessary to remove residual product from the mixers, bins, trollies prior to
cleaning and to reduce cleaning or disinfection chemicals on the line to a maximum acceptable level
after cleaning. Cleaning chemicals must be stored in a dedicated store.

8.3. Cleaning

Dry or non- aqueous processes ideally should be cleaned by a dry cleaning method. For drying this can
be done by utensils like brushes, scrapers or vacuum cleaners or by means of another suitable method
like flushing out of residual product by cleaning salt or sugar. Wet cleaning should start with physical
removal of food residues and soil, to minimize water use and optimize the cleaning effectiveness. In
open processes this can be done manually with tools like scrapers, shovels or brushes. Because of the
risk of cross contamination (allergens, micro-organisms) high-pressure equipment should not be used for
cleaning.
Where detergents are used, the hardness of water must be taken in to account versus the concentration and
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type of cleaning agents used to ensure the effectiveness of the process.

The typical sequence of wet cleaning is

Pre-rinse
Detergent wash
Final rinse
Disinfection(if applicable)
Process lines should preferably be cleaned immediately after production. Floors should be kept dry as much
as possible during production and after cleaning and floor drains must be regularly cleaned. Care must be
taken to prevent foreign body contamination from cleaning equipment like brushes.

8.4 Disinfection

Depending on equipment and /or process, disinfection can be done either by heat, hot water or by
disinfecting chemicals. Disinfection should always be preceded by an adequate cleaning procedure,
unless a combined method (e.g. alkaline detergent wash>80 C) has proven to be effective. And its
verification by swabs results.

8.5 Cleaning Out of Place (COP) / Cleaning in Places (CIP)

The control of COP / CIP systems must be integrated in HACCP or be part of a pre-requisite program.
Typical parameters to be designed in to the system and monitored are:
Detergent and disinfectant concentration
Flow rate and contact time
Minimum water and equipment temperatures.

To prevent contamination with cleaning chemicals, the COP / CIP system must always be adequately
separated from product lines during production.

8.6. Pest Control

Pests can be a source of microbiological and physical contamination. All operations must identify
relevant pests and take preventative measures to avoid infestation and minimize the use of, and the risks
associated with pesticides. Pest control requires specialized skills and should be carried out by a reputable
company, using trained people and incompliance with legislation. An employee must be nominated to
monitor the effectiveness of the pest control program and to follow up on pest control reports and missing
baits. A pest control program must be implemented containing the following elements:
Identification and elimination of pest access points.
Identification of target organisms and adequate prevention procedures based on local circumstances.
An up-to-date site map indicating position of pest control traps and chemicals used.
Indication of baits by means of signs.
Reporting of the results of the pest control program and corrective action plans to the relevant
departments.
Investigation of missing baits, incase poisonous baits are used inside the factory.
Storage of the pest control chemicals in such a way that they cannot contaminate raw materials and
product, preferably off-site.
Monitoring of the pest control program to review the effectiveness and determine corrective actions.

A pest control program should contain the following security elements:

To en case, lock and secure bait traps that they cannot be removed easily.
Locking up of storage cabinets or rooms containing pesticides to prevent misuse.
Using toxic bait traps outside manufacturing areas only.
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 I fit is necessary to use poisonous baits inside the manufacturing area, to regularly verify whether
there is no unaccounted poisonous material missing.
Furthermore monitoring devices should be strategically located throughout internal and external areas.

Insectocutors must not be installed near exposed food. They must be positioned to avoid attracting insects
in to processing areas and should be cleaned regularly. UV lamps must be protected from shattering and
should be changed regularly to guarantee effectiveness.

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9. Personnel & Training

Objectives

To ensure that all personnel are adequately trained in basic food hygiene for food handlers, understand
potential relevant critical aspects of product quality & safety and their required actions in case of non-
conformities.

To ensure that all personnel who come directly or indirectly into contact with food:
Maintain an appropriate level of personal cleanliness and report communicable diseases likely to
be transmitted through food
Behave and operate in an appropriate manner to protect the safety and quality of the food

9.1 Training Standards

All personnel must have the following skills and competencies:

Understanding of the requirements in personal hygiene, the companys quality or Food safety
policy and its intentions.
Knowledge of and the ability to apply control procedures and work instructions and understanding
the min the context of food safety and quality.
An appropriate level of training in HACCP / FSMS /QMS/ FSSC.
To perform required actions in case of identified non-conformities.
To know and understand relevant parts of CFL GMP requirements.

All personnel must know and understand their tasks and responsibilities, particularly on food safety
aspects. These should be laid down in job descriptions. Training should explain not only what is
important, but also why it is important. The employees understanding of the training should be verified.
Training records must be kept and training must be regularly updated.

9.2 Communicable diseases, injuries & health screening

Any person known or suspected to be suffering from, or carrying a disease likely to be transmitted through
food / Biscuit must immediately report this to management. This is especially relevant when employees
have been visiting areas where enteric and other food borne diseases are endemic. The management must
ensure that these persons do not have access to an area where unpacked Biscuit products or materials are
handled if there is any risk of food contamination.

Guidelines on health screening, medical examination of food handlers, as well as on administrative

procedures and payment during exclusion from work, are given in "Health screening of food handlers

9.3 Sanitary and personal hygiene procedures

Personal hygiene and training is fundamental to hygienic manufacture. Rules for hygienic behavior must
be issued to all staff including temporary or sub-contract personnel in written form and also to
contractors and visitors. Supervisory staff must ensure that employees have understood these
instructions.
Personnel working in production areas must be instructed to wash their hands immediately prior to
starting work, re-starting after breaks and use of a toilet, and whenever necessary during work to
prevent product contamination. Liquid soap, hand sanitizers should be used, as soap bars can
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 introduce a microbiological hazard.
All personnel in processing areas must wear clean or Company provided clothing. All pockets must be
on the inside. Work clothes should be fastened by using press-studs or zips rather than buttons. Clean
clothing insufficient quantity must be provided. The employee must change his/ her clothing as
frequently as necessary in order to meet hygienic requirements. Work clothing must not be worn outside
the factory premises.
Head gear (e.g. nets, hats) must be worn and cover all hair comprehensively. Beard snoods and
moustache covers should be used.
Where gloves are used they must be made of sufficient durability and not release toxic material; latex
should not be used as it introduces an allergen risk. Personnel must keep their hands and where relevant
their gloves clean or change gloves when they are dirty. Gloves do not add to hygiene compared to
properly washed hands.
Jewellery or watches must not be worn in manufacturing areas. Stud earrings, fixed body piercings
and plain wedding rings are not recommended; they may however be permitted at management
discretion or if covered by gloves or other protective clothing.
Finger nails must be cut short and kept clean. False nails or eye lashes must not be permitted.
Food consumption, chewing gum, smoking or other use of tobacco must be limited to dedicated areas
outside the manufacturing area. Spitting must not be permitted. The use of drugs is at all times
prohibited, except by medical prescription. Drugs must not be taken in food handling areas.
Drinking water points can be provided in food handling areas as long as there is no risk of cross-
contaminating the product. Where drinking water is provided, it must be potable.
Open wounds (cuts, sores, infected areas and other wounds) must be completely protected by protective
clothing or a water proof covering, colored contrasting to the food and preferably incorporating a metal
strip for easy detection. First aid provisions must be readily available. Doctors advice should be
obtained on the risk of contamination from open wounds and subsequent preventative measures.
Unprotected glass or hard plastics (other than packaging material and plastic glasses) should not be
taken into production areas.

9.4 Staff catering services

A staff eating or catering area must be provided and situated minimizing the risk of cross contamination
with raw materials and products. Food and drink to be served and consumed by personnel must not be
taken to the Biscuit handling areas.

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Appendix1. Prevention of glass / Wood/ metal foreign body hazards

1. Introduction

Contamination of Coronet products with glass/wood/metal or hard plastic that can shatter in to sharp pieces must be
regarded as a major problem for product safety and quality.

In order to protect the consumers and the corporate image we need to take all reasonable precautions to prevent
glass/wood/metal foreign body incidents. The aim of this guideline is to introduce preventative quality assurance and
good manufacturing practices to ensure that risks of glass/wood/metal foreign body hazards are in control.

Glass/wood/metal consumer complaints must be taken very seriously. Glass/wood/metal foreign body consumer
complaints must be followed up formally with recommended identification of the glass type and the potential source.

The first part of the guideline is generic and deals with the prevention of glass/wood/metal foreign bodies hazards
originating from the manufacturing operation. The second part specifically deals with hazards of glass/wood/metal
fragments, caused by the partial or complete fracture of glass containers, used for biscuits packaging.

Glass/wood/metal foreign body hazards must be controlled on the basis of the Hazard Analysis Critical Control point
system (HACCP).

2. Generic requirements

The prevention of glass/wood/metal foreign body contamination is based on adequate Hygiene & Housekeeping
procedures, training of employees and pre requisite programs.

1 In all production areas glass should be replaced by shatter proof material or provided with an anti-shatter film.
Windows must be break proof or protected, if shattering can introduce a glass hazard to products

2 Measuring devices (thermometers, electrodes, pressure gauges etc.) should be made of non-glass if alternatives
are available. For instance, sight glasses in production lines, subjected to temperature fluctuations, should be
of non-glass materials such as polysulphon. Where the application of glass devices cannot be designed out, the
risk of breakage must be evaluated involving information available from the supplier.

3 Lighting or infrared lamps in all production and storage areas (including off site warehouses managed by
third parties) must be equipped with an appropriate cover or shatter shields to catch glass fragments in case
of lamp breakage.

4 Laboratory sampling utensils (pipettes, flasks etc.) must be made of non-breakable material when used in the
production environment. There should be a strict control procedure for these items to ensure that all items
can be accounted for.

5 Any glass/wood/metal foreign bodies found in dough / Biscuit must trigger a thorough investigation to
identify the source and correct the problem.
6 A register / document should be available of all glass items on site.

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Appendix2. Abbreviations

CCPs Critical Control Points

COP Cleaning Out of Place
DC Design Control
DCPs Design Control Points
FIFO First In First Out
FWS Frame Work Standards
GMO Genetically Modified Organism
GMP Good Manufacturing Practice
HACCP Hazard Analysis Critical Control Points
IPM Innovation Process Management
ISO International Standards Organization
MSDS Material Safety Data Sheets
QA Quality Assurance
QCPs Quality Control Points

CFL Coronet Foods Pvt. Limited

WHO World Health Organization

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