PRP Manual: Revision History: Effective Date Reason For Issue

General Document not to circulate and copy
STANDARD OPERATING PROCEDURE Document No. : /QA/0

After 7 days From the last date of
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Review date : One years from the effective date
PRP MANUAL Supersedes :
Issue No. : 00
Page No. : Page 1 of 44
Prepared by Approved by Authorized by
Asst. QA Manager QA Manager General Manager

Date: Date: Date:
REVISION HISTORY:
Version Effective Date Reason for issue
From Dr Manoj Gandhi

STANDARD OPERATING PROCEDURE Document No. : /QA/Document no. to be added
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PRP SEC. Revision Title Page No.

/Sec. No. No.
00 00 Contents 1-3
00 00 Amendment Sheet 4
01 00 Scope 4-5
02 00 Normative Reference 5
03 00 Terms and Definitions 5-7
04 00 Construction and layout of Buildings 7-8
05 00 Layout of Premises and Workspace 8-10
06 00 Utilities – Air, Water and Energy 11-13
07 00 Waste Disposal 14-15
08 00 Equipment Suitability, Cleaning, Maintenance & Calibration 16-18
09 00 Management of purchase material and supplies

19-20
10 00 Measures for Prevention of Cross Contamination
21-25
11 00 Cleaning and Sanitation
26-27
12 01 Pest Control
28-30
13 01 Personal Hygiene and Employee Facilities
31-34
14 00 Rework
34
15 00 Product recall
35-37
16 00 Warehousing
38-39
17 00 Product information/consumer awareness
Food Defense, Food Fraud Prevention, Bio vigilance and 39
18 00 Bioterrorism (TACCP& VACCP)
40-44
Appendix 01 - Building Layout for manufacturing process

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Appendix 03 – List of authorized personnel to enter sensitive area.

Appendix 04–Material movement for Mix section
Appendix 05 –Men movement for Mix section
Appendix 06 – Material movement for First and Second floor production
Appendix 07 –Men movement for First floor and second floor production
Appendix 08 –Water layout
Appendix 09 –Water and waste water flow at glance
Appendix 10 –Compressed air supply map
Appendix 11 –Used water for ETP Treatment Line
Appendix 12 – Equipment list
Appendix13 – Preventive Maintenance schedule
Appendix 14 – Fire Extinguisher list
Appendix 15 – Colour Coding Cleaning Tools
Appendix 16 – Supplier Approval and control
Appendix 17 – Glass Bristle Plastic management procedure
Appendix 18 – Glass breakage checking record
Appendix 19 – Verification of PRP
Appendix 20 – Cleaning and sanitation
Appendix 21 – Pest Control Mapping
Appendix 22 – Visitors Policy
Appendix-23- Daily personal hygiene checklist
Appendix 24– Medical certificate
Appendix 25 – Detail of the Product recall /withdrawal in FID/QA/039
(MOCK RECALL)
Appendix 26 – Potentially Sensitive Areas and its Access control
Appendix 27 – Food defense shelf Assessment
Appendix 28 - RM Layout for Cakes
Appendix -29 Men & material Layout Cakes - P_QFS_HACCP_7.5-
01_008_01
Appendix -30 water Layout Cakes- P_QFS_HACCP(G)_7.5-01
Appendix -31 Compressed air supply map for Cakes plant –
FID//QA/54/A:3.6
Appendix-32 Threat and Vulnerability assessment- FID/QA/57-A2

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AMENDMENTS
Amendment Discard
Details of amendment
Section Rev. No. Date Section Rev. no. Date

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1. SCOPE
This Technical Specification is applicable to all organizations, regardless of size or complexity, which is involved
in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the
requirements specified in ISO 22000:2018, Clause 8.2.
The Technical Specification is neither designed nor intended for use in other parts of the food supply chain.
Food manufacturing operations are diverse in nature and not all of the requirements specified in this Technical
Specification apply to an individual establishment or process.
Where exclusions are made or alternative measures implemented, these need to be justified and documented.
by a hazard analysis, as described in ISO 22000:2018, 8.5. Any exclusions or alternative measures adopted
should not affect the ability of the organization to comply with these requirements.
This technical specification specifies detailed requirements to be specifically considered in relation to

ISO 22000:2005, 7.1.6.
1. Construction and layout of buildings and associated buildings

2. Layout of premises, including workspace and employee facilities.
3. Supplies of air, water, energy, and other utilities
4. Supporting services, including waste and sewage disposal.
5. Suitability of equipment and its accessibility for cleaning, maintenance, and preventive maintenance.
6. Management of purchased materials.
7. Measures for prevention of cross contamination
8. Cleaning and Sanitizing
9. Pest Control
10. Personal Hygiene
In addition, this technical specification adds other aspects which are considered relevant to manufacturing
operations.
1. Rework
2. Product recall procedure
3. Product information and consumer awareness
4. Food defense, biovigilance and bioterrorism.

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2 NORMATIVE REFERENCES
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 22002:2009, Food safety management systems – Requirements for any organization in the food chain.
3. TERMS AND DEFINITIONS
3.1 Contamination: Introduction or occurrence of contaminant in food or food environment.
3.2 Contaminant : Any biological or chemical agent, foreign matter or other substances not intentionally added to
food which may compromise food safety or suitability.
3.3 Establishment : Any building or area in which food is handled, and the surroundings, under the control of the
same management.
3.4 Materials : Term used to indicate raw materials, packaging materials, ingredients, process. aids, cleaning
materials and lubricants.
3.5 Cleaning : Removal of soil, food residue, dirt, grease, or objectionable matter.
3.6 Product Contact : All surfaces that are in contact with the product or the primary package. during the normal
operation.
3.7 Material Specification (Product Specification): Detailed documented description or enumeration of

parameters, including permissible variations and tolerences, which are required to achieve a defined level of
acceptability or quality.
3.8 Food grade : Lubricants and heat transfer fluids formulated to be suitable for use in food processes where there
may be incidental contact between the lubricant and the food.
3.9 Disinfection : reduction by means of chemical agents and/or physical methods, of the number of micro-
organisms in the environment, to a level that does not compromise food safety or suitability
3.10 Cleaning in place (CIP) : Cleaning of equipment by impingement or circulation of flowing chemical solutions,
cleaning liquids and water rinses into, on to and over surfaces in equipment or systems without dismantling and
designed for the purpose.
3.11 Cleaning out of place (COP) : System where equipment is disassembled and cleaned in a Tank or in a
automatic washer by circulating a cleaning solution and maintaining a inimum temperature throughout the cleaning
cycle.

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3.12 Sanitizing : The process of cleaning followed by disinfection.
3.13 Sanitation : All actions dealing with cleaning or maintaining hygienic conditions in an establishment,
ranging from cleaning and/or sanitizing of specific equipment to periodic cleaning activities throughout the
establishment (including building, structural, and grounds cleaning activities)
3.14 Certificate of Analysis : Document provided by the supplier which indicates results of specific tests/analysis,
including test methodology, performed on defined lot of the supplier’s product.
3.15 Zoning : Demarcation of an area within an establishment where specific operating, hygiene or other practices
may be applied to minimize the potential for microbiological cross contamination.
Examples of practices include Clothing change on entry or exit, Positive air pressure, modified traffic flow patterns.
3.16 Label: Printed matter that is part of the finished product package conveying specific information about the
contents of the package, the food ingredients and any storage and preparation requirements.
Example: The term covers, but is not limited to:
a) The package itself, printed matter attached to the package, or a sticker used for over – labeling.
b) Multi packs which have an inner label on the individual product and an outer combined label for the whole
contents.
3.17 Product Recall: Removal of a Non – Confirming product from the market, trade and warehouse, distribution
centers and/or customer warehouses because it does not meet specified standards.
3.18 First Expired First Out (FEFO) : Stock rotation based on the principle of dispatching earliest expiration dates
first.
3.19 First in First Out (FIFO) : Stock rotation based on the principle of dispatching earliest received products first.

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4. CONSTRUCTION AND LAYOUT OF BUILDING
4.1 General Requirements:

Building shall be designed, constructed, and maintained in a manner appropriate to the nature of the processing
operations to be carried out, the food safety hazards associated with those operations and the potential sources of
contamination from the plant environs. Buildings shall be of durable construction which presents no hazard to the
product.
4.2 Environment:
Consideration shall be given to potential sources of contamination from the local environment .Food production
should not be carried out in areas where potentially harmful substances could enter the product.
The effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed.
4.3 Location of Establishments:

The site boundaries shall be clearly identified Access to the site shall be controlled The site shall be
maintained in good order. Vegetable shall be tended or removed. Roads, yards And parking areas shall be
drained to prevent standing water and shall be maintained.
REF: Appendix -1 Appendix 01 - Building Layout for manufacturing process
Appendix 28 - RM Layout for Cakes
Appendix -3 List of Authorized Personnel to Enter Sensitive Areas – SOP/FID/QA/___
5. LAYOUT OF PREMISES AND WORKSPACE

Internal Layouts shall be designed, constructed, and maintained to facilitate good Hygiene and Manufacturing
Practices. The Movement patterns of materials, products and people, and the layout of equipment, shall be
designed to protect against potential contamination sources.
5.2 Internal Design, layout and Traffic Patterns:

1. The building should have adequate space, with logical flow of materials, product, and personnel.
2. There should be defined areas or other control systems for the following activities so as to prevent
cross contamination. Segregation can be provided by means of walls, barriers, or partitions.
• Raw Material Storage
• Packaging Material storage

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• Storage of Finished Products

• Storage of Nonconforming Material
• Men Movement
3. Openings or windows intended for transfer of the material should be protected to prevent entry of
foreign matter and pests.
5.3 Internal Structure and Fittings :
1. Process area walls and floor shall be designed and maintained to facilitate washing and cleaning.
Materials used for construction should be resistant to cleaning material to be used. Wall floor junctions
and corners shall be designed to facilitate cleaning. Floor shall be designed and maintained to prevent
standing water.
2. In wet process area floor shall be free of cracks and gaps or if unavoidable shall be
sealed properly to prevent harborage of the pests.
3. Walls and partitions should have a smooth surface up to a height appropriate for the operation.
4. Ceilings and overhead structures shall be designed and maintained to minimize build up of dirt and
condensation.
5. External opening windows, roof vents or exhaust fans should be constructed or designed to facilitate
cleaning, and to minimize buildup of dirt. Where necessary cleanable insect proof screens shall be
provided.
6. Drains shall be designed and maintained so that flow is always away from production areas and shall
be trapped and covered.
7. External opening doors shall be closed or screened when not in use.
5.4 Location of Equipment’s

Equipment’s shall be designed and located So As To facilitate good hygiene practices,
monitoring and shall permit easy access for operation, cleaning and maintenance.
5.5 Laboratory Facilities

1. In-line and on-line test facilities in the laboratory shall be controlled to minimize the risk of product
contamination.
2. Microbiological laboratory shall be designed, located and operated so as to prevent contamination of
people, plant and products. Production process should not adversely affect the accuracy of the
laboratory measurements and vice versa. It shall not directly open into the production area.
5.6 Temporary or Mobile Premises

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Temporary structures shall be designed, located and constructed so as to avoid pest harborage and potential
contamination of products. Additional hazards associated with such structures shall be assessed and
controlled.
5.7 Storage of food, packaging materials, ingredients and non food chemicals
1. Facilities used for storage of ingredients, packaging and products shall provide
protection from dust, condensation, drains, waste and other sources of contamination.
2. Storage areas shall be dry and well ventilated. Monitoring and control of temperature and humidity
shall be applied where specified.
3. Storage area shall be designed or arranged to allow segregation of raw material, work
in progress and finished products.
4. All the materials and products shall be stored off the floor and with sufficient space between the
material and the walls to allow inspection and pest control activities to be carried out.
5. In case of seasonal bulk Agricultural material there will be exception up to certain level for storage
due to large space involved in the storage and the same shall be documented in the food safety
management system.
6. Storage area shall be designed to allow maintenance and cleaning, prevent contamination and minimize
deterioration.
7. Separate secured (locked or access controlled) storage area shall provided for the cleaning materials.
Chemicals and other hazardous substances.
Reference:
Appendix -4 Material movement for Mix section - FID/QA/54:A:03:01
Appendix -5Men Movement for Mix- FID/QA/54:A:03:02
Appendix -6 Material Movement for First and second floor - FID/QA/54:A:03:03
Appendix -7 Men Movement for First and second floor production- FID/QA/54:A:03:04
Appendix -28 RM Layout Cakes- C_QFS_HACCP_7.5-01_008_01
Appendix 29 Men & Material Layout Cakes –FID/QA/54/A:03.9

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6. UITILITIES – AIR, WATER AND ENERGY

The provision and distribution routes for utilities to and around the processing and storage areas
shall be designed to minimize the risk of product contamination. Quality of the utilities shall be
monitored to minimize product contamination risk.
6.2 Water Supply:
Water wherever used in the production, likely to come in contact with food shall be of potable
quality and sufficient to meet the needs of the production process (es).
Facilities for storage, distribution and where needed, shall be designed to meet specified water
quality requirement.
Potable water should conform to the WHO/BIS guidelines for drinking water quality.
Water used as product ingredient, should meet specified quality and microbiological requirements
relevant to the product.
Water for cleaning or applications where there is risk of indirect product contacts(eg. Jacketed vessel
or heat exchangers), should meet specified quality and microbiological requirements relevant to the
application.
Wherever chlorinated water is used, checks should ensure that residual chlorine level at the point of
use remains within the limits given in the specification.
Non potable water supply shall have separate supply system with proper identification and not
connected to the potable water supply system. Measures should be taken to prevent non – potable
water refluxing into the potable system.
This implies that entire water supply must pass through a filtration system followed by disinfection
by UV treatment unit.
Wherever RO water is used, checks should ensure that residual chlorine, Ph level and turbidity at the
point of use remains within the limits given in the specification.
Specifically, potable water is used in the following applications –
1. Production Processes
2. Equipment / Utensil, cleaning and disinfection
3. Cleaning / Disinfection of areas
Drinking purpose Control measures would include –

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1. Turbidity for visually Daily and weekly by turbidity meter

2. pH for incoming water –Daily
3. Free chlorine (After RO)-Daily
4. Microbiological assessment
Once a week/monthly – In-house laboratory (from different outlet points at random)
Twice in a year – External laboratory as per IS 10500: 2012 (Drinking water standard)
6.3 Boiler Chemicals –

Boiler chemical if used shall be either
Approved food additives which meets relevant additive specifications or
Additives which have been approved by the relevant regulatory authority as safe for use in water
intended for human consumption.
All the boiler chemicals shall be stored in a separate and secure area when not in immediate use.
6.4 Air quality and Ventilation

Where air is coming in direct contact of products, requirement for filtration, humidity and microbiological
analysis shall be fulfilled at predetermined frequencies.
Where temperature and or humidity are deemed critical by the organization, a control system shall be put in place
and monitored.
Ventilation (Natural or Mechanical) shall be provided wherever necessary to remove dust, odours If necessary
room air supply should be controlled to minimize the risk airborne Microbiological contamination. Protocols for
air quality monitoring shall be established in areas where products which supports growth or survival of
microorganisms are exposed.
Ventilation systems shall be designed and constructed such that air does not flow from contaminated or raw areas
to clean areas.
Specified air pressure differentials shall be maintained.
Ventilation system shall be accessible for cleaning, filter changing and maintenance.
Exterior air intake ports should be examined periodically for physical integrity.
6.5 Compressed air and other gases

Compressed air and gas system used in manufacturing and /or filing should be constructed and maintained so as
to prevent contamination.
Gases intended for direct or incidental product contact (including those used for transporting, blowing or drying

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materials, products or equipment) shall be from a source approved for food contact use, filtered to remove dust,
oil and water.
Where oil is used for compressors and there is potential for the air to come into contact with the food, the oil used
shall be of food grade quality. Use of means like filtration shall be used to minimize the risk of contamination.
Examination of filters for its integrity shall be specified.
6.6 Lighting
The lighting provided (natural or artificial) shall allow personnel to operate in a hygienic manner. Intensity of the
lighting should be appropriate to the nature of the operation.
Light fixtures shall be protected to ensure that the materials, products, or equipment are not contaminated in case
of breakages.
Reference: Appendix -8 Water layout –FID/QA/54:A:03.5

Appendix -9 Water & waste water flow at glance - FID/QA/54:A:03.5.1
Appendix -10 Compressed air supply map – FID/QA/54/A:3.6
Appendix -30 Cakes water layout – C_QFS_HACCP(G)_7.5-01
Appendix -31 Compressed air supply map for Cakes plant – FID/QA/54/A:3.6

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7 WASTE DISPOSALS
7.1 General Requirements

Adequate waste disposal systems and facilities are provided. Waste material are identified, collected, removed
and disposed of in a manner which prevents contamination of products or production areas. Waste disposal is
done thru govt. approved or licensed vendor.
7.2 Containers for waste and hazardous substances: containers for waste and hazardous substances are,
1. Clearly identified for their intended purpose.
2. Located in designated area.
3. Constructed of impervious material which can be readily cleaned and sanitized.
4. Closed when not in immediate use
5. Locked where the waste may pose a risk to the product.
7.3 Waste management and removal:

System for segregation, storage and removal of waste is in place. Waste is removed from the particular area as
and when required so as to avoid accumulation.
Labeled materials, products or printed packing materials considered as waste will be disfigured or destroyed to
ensure that trademarks cannot be reused
Removal and destruction of all the waste is done by approved disposal contractor. Records of the destruction will
be maintained.
Waste management for different waste is managed in following manner.
Waste Management:
BIO-DEGRADABLE WASTE / NON CONFORMING PRODUCTS
1. Waste Non conforming products are collected in garbage drum (with garbage bags) placed in respective
sections.
2. Garbage bags are tied and removed to designated garbage area after regular interval or whenever required.
3. Garbage contractor collects the garbage on a daily basis or alternate day or as per requirement.
4. Media disposal is done as per SOP mentioned in lab manual.

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RECYCLABLE WASTE:
1. Packaging materials and paper waste are collected on a daily basis from garbage drums (with garbage bags)
located in different areas. Any printed packaging material is disfigured to avoid reuse of it.
2. At the end of the shift all waste is transferred to garbage area.
3. Waste dealer collects the material as per requirement.
Waste storage area is placed far from the production area.
LIQUID WASTE
Liquid waste is sent to ETP. ETP treated water is used for gardening and Sludge coming out of ETP is collected in
bags specially made for the purpose and used as manure for Garden or sold to the PCB approved vendors.
HAZARDOUS WASTE
Hazardous wastes like used lubricant oil. All these stored wastes is handed over to govt. approved agency for
handling such waste once in a six month.
RECALL /WITHDRAWAL PRODUCT
Recall/Withdrawal product will be disposed into garbage bag and will be disposed as solid waste through
designated garbage contractor.
7.3 Drains and Drainage

Drains shall be designed, constructed and located so that the risk of contamination of materials or products is
avoided. Drains shall have capacity sufficient to remove expected flow loads. Drains shall not pass over processing
lines.
Drainage direction shall not flow from a contaminated area to a clean area.
Reference: Appendix -11 Used water for ETP Treatment line – FID/QA/054:A:03.5.1

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8 EQUIPMENT SUITABILITY, CLEANING AND MAINTENANCE

Food contact equipment’s are designed and constructed to facilitate cleaning, disinfection and maintenance. Food
contact surfaces are constructed and designed with materials which will not get affected by the intended product or
cleaning system. All the food contact surfaces are made of food grade material. Where necessary, equipment’s are
durable and movable or capable of being dismantled to allow for maintenance, cleaning, disinfection, monitoring
etc.
8.2 Hygienic Design
Physical hazard can result through part of equipment breaking off and gaining entry to the product. Alternately if
equipment has any dead-leg areas, is difficult to clean or is poorly cleaned. Microbiological buildup could
contaminate the product. Chemical contamination could occur through lubricants (grease) or cleaning residues
remaining on the equipment food contact surfaces.
All the equipment’s used for manufacturing are designed and constructed to meet established principles of Hygienic
design including,
1. Smooth, accessible and cleanable surfaces
2. Use of materials compatible with intended products and cleaning or flushing agents.
3. Framework not penetrated by holes or nuts and bolts.
All the pipelines and ductwork are cleanable, drainable and with no dead ends.
Equipment’s are designed to minimize the contact between the operators hands and the products.
8.3 Food Contact surfaces: All the product contact surfaces used in the manufacturing are made up of food grade
material and are impermeable and rust and corrosion free.
8.4 Temperature control and monitoring equipment: Equipment’s used for thermal processes are designed to
withstand the temperature gradient and holding conditions given in relevant product specifications.
Equipment is made suitable to access the monitoring and control of the temperature.
cleaning programmers are established, implemented and documented to ensure that all plant, utensils, and
equipment’s are cleaned at defined frequencies.
8.5 Cleaning plant, utensils and equipment’s:

Cleaning programmers specify in detail in cleaning procedure, responsibility, use of cleaning tools (Colur coded)
and methods for verification of the effectiveness of cleaning wherever necessary.

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Various control measures in respect of equipment would include:

1. Cleaning and sanitizing before use.
2. Checking the effectiveness through Swab Testing.
3. Physical inspection for cleanliness and pest infection.
4. In depth cleaning, sanitizing and maintenance schedules.
Risk assessment
Risk assessment has been carried for all existing equipment’s and is now being conducted for all new
equipment’s during installation for adequate safety measures during usage. Same has also been documented
accordingly.
8.6 Preventive and corrective maintenance
The goal of the Preventive Maintenance Program is to maintain the process environment to optimize production
and minimize food safety risks and equipment failures. The program has to be very aggressive in order to meet
that goal.
Maintenance requests which impact product safety shall be given priority.
Corrective Maintenance shall be carried out in such a way that production on adjoining lines or equipment is not
at risk of contamination.
Preventive maintenance program is established, implemented and documented for all the equipment’s in the plant
including monitoring and measuring equipment’s. Equipment’s are maintained as per manufacturer’s
recommendations, equipment history, and past experiences. Tasks include inspecting, monitoring, lubricating,
and replacing parts.
Equipment check list is maintained For all the equipment’s in factory on daily basis for certain critical
equipment’s/machines. Annual Maintenance contract is in place wherever required.
8.7 Calibration
Calibration is carried out in the accredited laboratory as per the defined frequency records of the same
will be available in the site.
A complete list of equipment and tracker for the schedule of calibration is available.
LUBRICANTS: Lubrication is a critical element of any Preventive Maintenance Program.
Lubricants heat transfer fluids used are of food grade quality to minimize the risk of food safety hazard.
Inventory control is another concerned area of the Maintenance Program. In certain critical area where
there is risk of contamination from outside sources, maintenance tools required for such section are

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stored in the that section itself at dedicated place for the same.
At other places where maintenance tools needs to be carried by the maintenance person, proper check is needed
to avoid missing of any tool which may gain entry into the product leading to major food safety concern. To
avoid such instances maintenance team has been trained on the related issues and preventive measures to be
taken.
Preventive Maintenance schedule is in place for all the necessary equipment’s and related records are maintained.
Risk assessment for the equipment’s has been carried out and documented. Where ever possible Machines/
equipment’s, which are not in use are segregated and kept separately away from the process area.
TEMPORARY REPAIR POLICY: In day-to-day operations temporary repair or maintenance may be required.
In such a situation production personnel shall intimate regarding the problem/repair to concerned maintenance
team. Wherever possible machine/equipment under temporary repair shall be taken out of the process area.
Before repair through cleaning of the machine/equipment shall be done. Once the problem is solved, machine
shall be checked for any loose parts, bolts, nuts which may carry to products. All the tools used for the repair
purpose shall be taken to its allocated place. Machine shall be thoroughly cleaned as per the procedure after
handed over by the maintenance team to production and then only be used for its routine purpose. All such
temporary repair/Maintenance shall be recorded.
For adequate addressing to emergency situations following steps have been taken and defined in plant layouts–
1. Assembly point
2. Fire extinguishers clearly depicted in layout for facility for all the necessary areas. Details about the same
are enclosed in subsequent pages.
3. Fire extinguisher list has been updated and is enclosed in subsequent pages.
Reference: Appendix 12: Equipment list (Mt),

Appendix 13: Preventive maintenance schedule,
Appendix 14: Fire extinguisher list
Appendix 15: Colour Coding Cleaning Tools. (as per SOP plant wise)

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9 MANAGEMENT OF PURCHASED MATERIALS, SUPPLIES
Purchasing of Raw materials, ingredients, Chemicals and packaging materials is done by procurement Dept.
procedure for selection, development and evaluation of Supplier are established, implemented and documented in
plant. Specifications for the purchased materials are established and documented. All the incoming material are
verified for their conformance to the defined criteria before accepting them into system.
9.2 Selection and management of suppliers:
Organization has well defined supplier approval & control which includes.
1. Supplier ability assessment to meet quality and food safety expectations, requirements and specifications.
2. Supplier’s plant evaluation includes site audit before prior to selecting the vendor.
3. Vendor selection
4. Vendor Approval
5. Supplier performance assessment for continued approval status thru monitoring of conformance to material
specifications, meeting COA requirement or satisfactory audit outcome.
9.3 Incoming Material Requirements (Raw/Ingredients/Packaging)
With regards to Food safety quality of the incoming material is very important as it may act as direct or indirect
source of contamination leading to food safety hazard. To comply with this organization has well established
procedure to monitor and control the processes, steps or any activity which can affect the final product quality.
This is achieved by implementing practices mentioned below.
1. Inspection of incoming delivery prior to, and during unloading to verify that the quality and safety of the
material has been maintained during transit. This includes intactness of seal, free from infestation,
temperature or any relevant criteria.
2. Inspection and testing of all received materials (Raw material, packaging material, chemicals &
ingredients) to ensure its conformance with defined specifications.
3. Non conforming material is kept under hold till decision regarding the same is taken or sent back to
supplier. Materials under hold will not be used till clearance from the Quality Assurance Department.
Wherever necessary material is accepted on the basis of the “Certificate Of Analysis” and verified to ensure
its conformance before use.

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Storage:
Storage areas are maintained so as to minimize spoilage and cross contamination issues.
Areas have been designated and easily identifiable for storage of raw material, packaging material, WIP material
and finished goods. “First in First Out” (FIFO) principle is used across the plant for specified product rotation
and inventory control schedule. All the materials are stored at temperatures that maintain the product in safe
condition. Product identity in storage is also maintained to adhere to traceability system.
Wherever required fumigation is done for the raw materials and packing materials. Fumigation is carried out by
approved agency by the central govt. of India for the Fumigation. Details of the fumigation process chemicals
used documented.
Material, across, bearing a specific shelf life is being reviewed continuously to trigger further action like quick
consumption, revalidation or new indent etc. as the case may be.
Hygienic design and operation considerations include:
1. Temperature: As per requirement
2. Avoid pest access and harborage.
3. Adequate segregation of food and non-food materials along with clear identification.
4. Resealing/covering of part used containers.
5. Strict observance of stock rotation first-in-first-out (FIFO) approach.
6. Adequate gap maintained of product stored from walls for easy inspection and easy walk space for inspection
and drawing material out.
7. Adequate pest control services like roda-boxes, fly control, fumigation.
8. Designated storage area for allergens
Various Control Measures include:
1. Regular physical inspection and inventory management as per usage and requirements
2. Ensuring proper and regular cleaning and inspections.
3. Regular manual monitoring of temperatures.
Water Supply: Water source for the plant is in house bore well. In house testing for water for its potability is
done daily for chemical parameters and once in a week for microbiological parameters and water is tested for
compliance to IS 10500-2012/WHO twice in year.
Reference: Appendix -16- Supplier approval and Control

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10. MEASURES FOR PREVENTION OF CROSS CONTAMINATION

To avoid cross contamination plant layout has been designed appropriately and wherever required, changes are
done. Program and procedures are in place to prevent, control and detect the contamination. Procedures or methods
include the measures to prevent physical, allergen and microbiological contamination.
10.2 Microbiological cross contamination

Areas such as Raw material receiving and preparation are separated by means of wall to avoid contamination as
this is having potential for microbiological cross contamination. Considering potential contamination sources,
susceptibility of the product and suitable control measure following preventive measures are implemented.
1. Separation of Raw from process
2. Structural segregation between different sections like, store, preparation, and WIP, Process, Packing and
Finished goods is done either by partitions or wall.
3. Permanent labors for different working sections to avoid contamination.
4. Controlled traffic pattern for workers, equipment’s and materials
5. Clean crates are used for the production purpose. Color coding system is implemented for crates.
6. Closed type of dust bins are used at all the points and waste is collected as and when required to avoid any
contamination from accumulated waste.
7. Wastage area is located away from the production premises to avoid microbiological contamination from
waste.
8. Good hygienic practices are implemented for all the employees to avoid nay microbiological contamination
from food handler. It includes daily hygiene check along with yearly medical checkup.
10.3 Allergen Management

Virtually all known food allergens are gluten, Milk, Sulphur dioxide, protein, Soya; they can be present in the food
and often survive in food-processing conditions. Whilst almost any food protein can cause an allergic reaction in
some people, the most common food allergens listed in the current allergen labeling legislation globally are,
Cereals containing gluten, Milk, Pea nuts, Tree Nuts (Almonds, Cashew, walnut Pistachio nut etc.), Egg, Fish,
Crustaceans, Soya, Sesame seeds, Mustard seeds and Sulphur dioxide and sulphites.
Allergens used as ingredient(s) in the products and stored in the plant are Milk (and its products), Tree nuts,
Lecithin and sulphites (in Sugar), Gluten (in refined flour).

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Allergens present in the product, either by design or by potential manufacturing cross contact, are identified and
declared in all the documents including product label in case of only one product.
Precaution is taken to avoid cross contamination of allergens when there is production of allergen containing
product followed by non allergen containing product by means of thorough cleaning.
The ingredients used in the various Products which are allergens will be handled in the following way.
1. Storage of Milk (and its products), Tree nuts, Lecithin and sulphites (in Sugar), Gluten (in refined
flour).will be done in an area marked with marking containing the word “Allergen/Allergic”
2. All the vessels and equipment’s will be cleaned properly following standard cleaning procedure after usage
of the same for handling allergens and using for product not containing allergen as ingredients.
All allergens should be managed to avoid their unintentional presence in products where ever possible. This
management involves evaluation of the likelihood of allergen cross-contamination associated with every step of
the food production process, from raw materials.
Key areas for consideration: The following key areas have been identified for effective allergen management.
1. Raw materials storage with separation for allergen material.

2. Manufacturing process and equipment – Processing of allergen material through discrepancy identified
between allergen profile on label and as manufactured.
3. Procedures in a shared equipment/environment after deep cleaning to avoid post usage contamination.
4. People –Training programs for workers are conducted on the consequences of allergies in sensitive
people.
5. Cleaning – Development of validated cleaning protocols and verification
6. Packaging and Communication.
Consumers are told about the potential risk in a simple & consistent way.
Allergen Hazard Analysis: During hazard identification the following aspects shall be considered.
a. Raw material /ingredients and their allergen status (right from purchasing of ingredients to end product /
throughout value chain)
b. Requirements of labeling.
Communication: Based on the hazard analysis, the allergen status is conveyed to consumer through clear labeling
and through website. The products that may contain traces of allergens will have appropriate allergy advice on the
label.
Verification: It is done whenever the risk assessment concerning the need for printing on label “MAY CONTAIN
MILK, GLUTEN, AND SULPHITE”, thus when there is a need to verify whether or not “may contain” labeling
is appropriate.
Review: During internal audit, emphasis is given for adequacy and adherence to procedures whenever
there is
a. Change of process / equipment
b. Change in cleaning, storage & usage protocols.

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Allergen status review is conducted along with HACCP review. Key areas for consideration: The following
key areas have been identified for effective allergen management.
1. Raw materials storage with separation for allergen material.

2. Manufacturing process and equipment – Processing of allergen material through validated procedures in
a shared equipment/environment after thorough cleaning to avoid post usage contamination.
3. People – Mapping of individuals movement and minimize contamination through’ workers as carriers
resulting in unintentional cross contamination. Training programs for workers are conducted on the
consequences of allergies in sensitive people.
4. Cleaning – Development of validated cleaning protocols and verification
5. Packaging and Communication.
The communications to sensitive consumers through labeling where in consumers are advised to refer to the
ingredients list for detailed information about the composition of the product and the presence of known
allergens. Advisory labeling is in close proximity to the ingredients list.
Consumers are told about the potential risk in a simple & consistent way.
Allergen Hazard Analysis: During hazard identification the following aspects shall be considered.
c. Raw material /ingredients and their allergen status (right from purchasing of ingredients to end product /
through out value chain)
d. Risk of contamination during production and packing (shared equipment, same production facilities,
workers movement etc)
e. Likelihood of cross contamination in storage and during transportation
f. Requirements of labeling.
g. Incorrect operation and/or failure of barriers leading to contamination.
Allergen hazard control: This means that appropriate preventive measures are taken to reduce the hazards to an
acceptable level. Some of the measures are segregation, production sequence on process line.
Communication: Based on the hazard analysis, the allergen status is conveyed to consumer through clear labeling.
The products that may contain traces of allergens will have appropriate allergy advice on the label.
Verification: It is done whenever the risk assessment concerning the need for printing on label “MAY CONTAIN
MILK, SULPHITES, GLUTEN, SOYA AND TREE NUTS”, thus when there is a need to verify whether or not
“may contain” labeling is appropriate.
Furthermore, verification of allergy control procedures is done by random testing of allergens from premises,
equipment and in the product. A negative result does not guarantee that all the other products are free from
allergen contamination. In allergen management, prevention is crucial for Product safety
Review: During internal audit, emphasis is given for adequacy and adherence to procedures whenever
there is
c. Recipe change
d. Change of process / equipment
e. Change in cleaning, storage & usage protocols.
Allergen status review is conducted once in a year along with HACCP review

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6.4 Physical Contamination

Where brittle materials are used, periodic inspection requirements and defined procedures in case of breakage
shall be put in place. Brittle materials such as glass and hard plastic components in equipment,
should be avoided where possible.
GLASS/BRITTLE PLASTIC POLICY

No use of glass in any form is allowed in raw material storage, preparation, mixing, packing No use of glass is
permitted except windows in civil construction and/or refurbishment of any of the above sensitive area (s).
1. No use of glass as a machine or equipment part is allowed in any of the production and packaging related
areas. In exceptional cases glass used will be covered with film so that after breakage glass pieces will not
get scattered.
2. No use of glass is allowed as a part of any measuring equipment in all areas except Laboratory.
3. Laboratory Glass wares are allowed to be used only in QA Lab. Stainless steel or Food grade plastic
containers shall be strictly used for sampling purposes.
4. All lamps & tube lights etc. in the above areas shall be covered with protection to prevent any glass
contamination by breakage etc.
5. No wristwatches and glass jewelries are allowed inside the production premises. Where ever wall clocks
are used shall be covered appropriately so as to prevent possible contamination after breakage.
6. Spectacles are not allowed for direct food handlers. If in case spectacle glass breakage occurs, concerned
official (supervisor in-place) to be immediately informed for further action.
a. If any Area: The area around where glass bottle is broken will be sealed / restricted for removal of all glass
pieces manually, by sweeping followed by mopping.
b. Any open material (raw material / intermediate product / final product) in the vicinity of
Glass or Brittle plastic breakage shall also be disposed off immediately following regular practice of
disposal.
7. All the glasses in the plant are identified and marked.
8. Glass and Brittle Plastic audit is in place check integrity of all the windows, tube lights, Wall clocks etc any
missing or broken glass or brittle plastic will be repaired/replaced immediately.
If any breakage or chipping occurs in case of brittle plastic materials like crates, dust bins, pressure guage,
Tube light, Fluorescent light covering, Production supervisor should be informed and the use of the same is
stopped in processing/storage area. Broken item will be replaced.

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9. A Master List of Glass and Brittle Plastic that indicates locations of all essential glass and brittle plastics
in the production and storage areas shall be maintained and kept current by the QA Manager. All
supervisors are responsible for immediately informing the QA Manager when glass/brittle plastics are
added and/or removed.
Reference: Appendix -17 Glass Bristle Plastic Management Procedure- SOP/FID/QA/059
Appendix -18 Glass Breakage checking record – FID/QA/059/A:01
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
Phase out policy for wood

1. Usage of wooden items other than aluminum partition in the plant shall be discouraged and restricted
wherever possible.
2. Usage of wooden items/accessories in any area shall be restricted in places where bare food is handled or
processed.
3. Items like wooden lab racks, if used, shall only be least used in storage of chemicals and shall be
replaced by iron door phase wise in three years of time.
11. CLEANING AND SANITATION

Cleaning and sanitation is an integral part of Pre requisite Program.
Cleaning is the removal of soil, food residue, dirt, grease or other objectionable matter.
Sanitizing is the reduction of micro-organisms to safe levels. Before sanitizing is achieved soil and food particles
must be removed from the surface of equipment and utensils. After washing in order to remove the food particles
and soil, the surface must be rinsed. Rinsing removes the detergent and remaining loose particles. Detergent must
be rinsed off as they reduce the effectiveness of sanitizer. Sanitizing is not a substitute of cleaning. Considering
all the above points, it is therefore, necessary to develop, implement and maintain cleaning system that is fully
adequate and cost effective.
11.2 Cleaning and Sanitizing agents and tools
Sanitization is done by the following methods.
1. Heat: Rinse temperature of water needs to be more than 45°C

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2. Chemical: Optimum concentrations of chemical sanitizers used are as follows:

Softsafe VC 19 : 1%
Divosan forte : 0.1 - 0.125%
Foam cleaning, SU 727 : 3-5%
Fogging SU 319 : 2%
Chlorine (Hypo) 50 – 100 ppm
IPA solution 70:30 proportion (70: IPA, 30: Water)
All the cleaning and sanitization agents and chemicals are clearly identifiable, food grade and are stored separately.
These are used according to supplier instruction or in house validated concentrations.
All the tools and equipment’s used for the cleaning purpose are of design suitable for the cleaning and sanitization
and maintained in the hygienic manner.
11.3 Cleaning and Sanitizing Programs

Organization has established validated, implemented and verified procedures for cleaning and sanitization clearly
indicating, equipment’s to be cleaned, methods of cleaning, tools required for cleaning, cleaning and sanitizing
agents to be used and responsibility of monitoring and verification.
While establishing standard operating procedures for cleaning and Sanitation various points are considered which
includes:
1. Definition of cleaning task.
This basically depends on type of food debris, dirt, dust etc.
a. Selection of optimal cleaning system.
b. Storage of Cleaning equipment’s.
c. Selection of optimal sanitizing system.
d. Cleaning & sanitizing schedules.
e. Color coding system for crates used for handling RM, WIP and FG.
11.4 Cleaning in place (CIP) systems only for plant

CIP line is used for mix section and is separate from the regular product line. Procedure for the CIP is in place and
monitored for concentration of cleaning chemical, contact time, and temperature applied for particular machine
through Scada system or visual or Chemical and Microbiological analyses.
11.5 Monitoring of sanitation effectiveness

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Procedure for checking Effectiveness of the sanitation is established, implemented, monitored and verified. Method
used to check effectiveness of sanitation is swab testing or rinse water of different equipment’s, food contact
surfaces etc. at predefined
Reference: Appendix -19 Verification of PRP: SOP/FID/QA/053

Appendix -20 Cleaning & Sanitization: SOP/FID/PROD/009
12. PEST CONTROL

Pests pose major threat to safety and suitability of food. Pest infestation can lead to contamination of food with
droppings, hair, and dead bodies or simply through contact. Control of pest infestation is not only and essential
component of PRP but also necessary to avoid legal prosecution and closure. Good hygiene practices have been
implemented to minimize the likelihood of infestation.
The pests mostly known for posing risk to food safety by contaminating or infesting food products in food
processing units include rats, mice, flies, cockroach, ants, weevils, bees, lizards, birds etc.
Common signs of pest infestation include:
1. Live or dead insects/rodents
2. Cockroach egg cases
3. A distinctive smell
4. Damage to buildings and foodstuffs by gnawing particularly on doors & windows.
5. Runaways, the rat will tend to use the same pathway each time it feeds. This will be worn and easily become
visible on inspection.
6. Droppings, the birds will leave their droppings roosting and perch areas. Rodents urinate and defecate
frequently. Hence, droppings would be found wherever rats feed or run.
Unclean premises, breakdown in food hygiene, storage practices lead to pest infestation and contamination.
12.2 Pest Control programs
To keep control on pests, a professional agency, Pest control India Ltd., has been hired for the for pest control
treatment of
1. Pied piper service (Rodent control)
2. Integrated fly management
3. Gold seal service
4. Service for Lizard control

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5. Integrated Spider management
Pesticide treatment services are managed by the trained personnel from the service providing agency.
Pest management programme is established and implemented considering following points
1. Identification of target pest.
2. Appropriate Pest control mapping.
3. Effective treatment schedules.
4. Methods of pest control.
5. Ensure use of approved public health pesticides.
6. Type, Concentration and quantity of the pesticide used.
7. No storage of pesticides (or empty container) in the premises.
8. Effective use of physical methods, pest-o-flash, air curtains, rat traps / roda boxes, bates & PVC strips etc.
9. All chemicals used for pest control are supported by ‘Material Safety Data Sheets (MSDS)’.
10. Adequate inspection (by in House /External agency) of the plant or structure at interval of three months
following corrective actions.
11. Use of Trend analysis to check the effectiveness of the pest control treatment.
12. Training is required where necessary.
Pest Control inside the plant is done on nonproduction day or when production is over. On the next day of the
treatment all the equipments and utensils are cleaned and sanitized as per the procedure before use.
To control pest areas both outside and inside the premises are kept clean. Refuse or waste from the unit is being
stored at a substantial distance from the production or storage sites. Establishment (inside) and surrounding areas
are regularly examined for evidence of infestation.
12.3 Preventing access

Buildings shall be maintained in good repair. Holes, drains and other potential pest access points shall be
sealed.
External doors, windows and ventilation openings are well protected to avoid possible entry of the pests
12.4 Harbourage and Infestations
Storage practices shall be designed to minimize the availability of food and water to pests.
Any infested material is handled in a manner to avoid the contamination of other materials, products or
establishments.
Whenever any material is stored outside care is taken to protect the material from weather or pest damage.

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12.5 Monitoring and detection

Pest monitoring programs includes.
1. Placing of glue trap or/and traps in key locations to identify the pest activity.
2. Mapping of traps.
3. Suitable design and location of the trap to prevent potential contamination of materials, products or
facilities.
4. Design of traps to be robust and temper resistant.
5. Defined frequency of monitoring the traps.
Facility inspection (assessment) is done by the Pest control of India (Contracted Pest control agency) once in a
three month and corrective actions are taken accordingly. Records of such inspection are maintained.
12.5 Eradication
Eradication measures shall be put in place immediately after evidence of infestation is reported.
Pesticide use and application shall be restricted to trained operatives and shall be controlled to avoid product
safety hazards.
Records of pesticide use shall be maintained to show the type, quantity and concentrations used, where, when and
how applied, and the target pest.
Reference: Appendix -21 Pest Control Mapping-FID/QA/COMM/026

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13. PERSONAL HYGIENE AND EMPLOYEE FACILITIES

Requirements for personal hygiene proportional to the hazard posed to the process area or product are established
and documented. It is necessary for all the personnel, visitors and contractors to comply with the documented
requirement.
13.2 Personal Hygiene and Toilets
Personal hygiene facilities are made available so as to ensure degree of personal hygiene required by the
organization is maintained. All the facilities are located at appropriate points and are clearly designated.
Organization has designed and maintained Personal hygiene facilities considering following points
1. Adequate number of washing station with drying and sanitizing facilities (whenever required) with
adequate supply of potable water and soap and/or sanitizer).
2. Wash stations provided for hand washing and for food or equipment washing are separately located as per
requirement.
3. Adequate number and appropriate type of toilets are provided with hand wash facility.
4. None of the employee hygiene facility directly opens in production, packing or storage area.
5. Change room facility for personnel is available.
6. Changing rooms are located away from the production, packing and storage area.
13.3 Staff canteens and designated eating areas.
Designated area for staff canteen and food storage is provided so as to minimize the cross contamination to
production areas.
Staff canteen and eating area are maintained in good hygienic condition
Employee’s own food shall be stored and consumed in designated areas only.
13.4 Work wear and protective clothing
To have good control on the possible contamination from work wear or protective clothing following control
measures are considered.
1. All the food handlers or are provided with work wear appropriate to the designated work. Work wears
are maintained in clean and good condition.
2. Work wears provided are having color coding through cap, which is different for each of the section so
that it cannot be used for the any other purpose or area.
3. Work wears are designed in such way so that buttons are not required and pockets above the waist level
are not there.
4. All workers and staff uniforms are washing in laundry by approved contractor. Laundry audit shall be
done once in a six month.

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5. Work wears are designed to provide adequate coverage to ensure that hair net etc. cannot contaminate the
product.
6. Hairs, moustaches and beard are protected with mask or beard net or as appropriately.
7. Where ever gloves are used for product contact, food grade and disposable gloves are used. Gloves are
changed as and when required or at joining work after every absence from the work area. Usage of gloves
is barred in places where there are high chances of gloves getting damaged while usage and its broken
pieces may contaminate the food.
8. Quality of the gloves has been validated in house for possible leech out of the material used and/or as per
ASTM D6319
9. Personal protective equipment’s where ever used are designed or designated so as to avoid product
contamination and maintained in good and hygienic condition.
13.5 Health Status

System is in place so that all the employees go thru medical checkup immediately after employment. Apart from
this all the employees undergoes medical checkup once in a year. All the employees are vaccinated against two
does of COVID vaccination and prevention against enteric diseases like Typhoid (Salmonella. Enteric group),
Hepatitis and Tetanus (Only for plant maintenance and utility departments).
13.6 Illness and Injuries
All the employees are checked for the symptoms of cough and cold, any injury, infected skin lesions (boils, cuts or
sores). Persons suffering from jaundice, diarrhea, vomiting, fever etc should immediately report to respective
department supervisors. This has been communicated to all the employees at the time of employment.
In case any person while working shows the one or more of the above-mentioned symptom, he or she will be
prevented from handling food or food contact materials.
Persons having wounds or burns are not allowed to work in area where he or she will come across the handling of
food or food contact material. The wounds must be covered appropriately and any loss of dressing shall be
reported to concerned supervisors.
13.7 Personal Cleanliness

Personnel working in the food production area shall be required to wash and sanitize (whenever required) hands.
Hand washing and /or sanitizing requires mainly
1. Before starting any food handling activities.
2. Immediately after using toilet or blowing nose.

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3. Immediately after handling any potentially contaminated material.

Employees are well communicated and trained to avoid.
a) Sneezing or coughing over the material or products.
b) Spitting in the premises.
c) Keeping fingernails clean and trimmed.
13.8 Personal behavior

People engaged in food handling refrain from behavior which could result in contamination of food. To
maintain good personal behavior practices in processing, packing and storage area following points are
considered.
1. Smoking and chewing of Tobacco products is strictly prohibited in factory premises.
2. Eating and water drinking is allowed at designated areas only.
3. Jewelries are not allowed inside the production, packing and storage area with exception to weeding
ornaments with proper protection (where ever applicable)
4. Use of nail polish. Eyelashes etc is not allowed inside the production, packing and storage area.
5. Maintenance of personal lockers in good repair and hygienic manner so as to avoid possible threat of
contamination and also shall be kept free from rubbish and soiled clothing.
6. Prohibition of product contact tools and equipments in personal lockers.
Organization has provided Control Measures to monitor and control the personal behavior which includes;
1. Physical inspection of food handler thru daily hygiene checklist.
2. Swab Testing of food handlers as verification of the sanitization
3. Organization has established implemented and documented Visitor policy.
4. Monitoring and verification of yearly medical examination by HR department
5. Frequent in house training to all the employees.
6. Monitoring and documentation of in house work wear washing.
7. Standard operating procedures, instruction or pictorial directions where ever required.
Reference - Appendix -22 Visitor policy

Appendix -23 Daily personal hygiene check list –FID/HR/004 F:001
Appendix -24 Medical certificate (File Document)- FID/HR/10 F:1:001

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14. REWORK
Clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or
that has been successfully reconditioned by reprocessing and that is suitable for use as food.
Rework shall be stored, handled and used in such a way that product safety, quality, traceability and Regulatory
compliance is maintained.
14.2 Storage, Identification and traceability
1. Stored reworked material will be protected from potential contamination.

2. Rework will be clearly identified and/or labeled to allow traceability.
3.
14.3 Rework Usage
1. Rework is incorporated as an “work in process” .

2. Rework activities involve removing a product from filled or wrapped packages.
IMPORTANT CONSIDERATIONS
1. Old rework shall be checked before use if requirement as per define frequency in SOP.

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15 PRODUCT RECALL

Recall and Withdrawals
The objective of product recall is to protect public health by informing consumers (where necessary) of the
presence on the market of a potentially hazardous foodstuff and by facilitating the efficient, rapid identification
and removal of unsafe foodstuffs from the distribution chain, to ensure that the unsafe foodstuffs are either
destroyed or rendered safe.
Classification of the level of product recall
Where food safety is concerned there are only two levels of product recall. These are:
Recall – the removal of unsafe food from the distribution chain that extends to food sold to consumers, and
therefore involves communication with consumers.
Withdrawal – the removal of an unsafe foodstuff from the distribution chain that does not extend to food sold to
the consumer.
Recall is a voluntary action taken by manufacturers and distributors to remove food which is in violation of laws
administered by Regulatory Authority. Product recovery is only classified as a recall when the product is violating.
The guidelines categorize all recalls into one of three classes according to the level of hazard involved.
Class I recalls are for dangerous or defective products that predictably could cause serious health
problems or death. Examples of products that could fall into this category are a food found to contain
botulinum toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective
artificial heart valve.
Class II recalls are for products that might cause a temporary health problem or pose only a slight threat
of a serious nature. One example is a drug that is under-strength but that is not used to treat life-
threatening situations.
Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violate
labeling or manufacturing regulations. Examples might be a container defect (plastic material
delaminating or a lid that does not seal); off-taste, color, or leaks in a bottled drink, and lack of English
labeling in a retail food.
15.2 Product Recall Requirements
For effective recall following points are most important
Product Identification

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Each batch or production lot of the product will be properly coded as described in SOP FID/PROD/010. This code
will allow the product lot to be identified as to date, batch product personnel production records, and ingredient
records.
Records
Records are key to the recall plan and must be maintained for Product shelf life+ one year They include:
Records of the suppliers of all ingredients and food processing materials.
Records of examination of raw materials, packaging materials, and finished product along with any supplier
guarantees or certifications.
Processing and production records showing the lot numbers of ingredients of each batch or lot and the code numbers
used to identify the lot in the warehouse or marketplace.
Records of initial distribution of the finished product adequate to facilitate separation of food lots which may have
become contaminated or otherwise unfit for use.
Notification
Persons to be notified in the event of a recall include Regulatory Authority, key company personnel, and
distributors. In the event of a recall, the media may also need to be notified. Only one employee should be assigned
the duty of spokesperson. Others should refer questions to him. The notification shall include the product, container
size, and code of affected lots. The notification should include instructions for consumers and distributors for
product recovery and information feedback. The contact person should be listed on the notification form.
Product Recovery
Plans for recovery include procedures for segregation of affected lots, storage, warehousing, and control.
Procedures in place shall allow determination of the effectiveness of the recall.
In the unlikely event of recalling product from the market place because of the any of the above, a product recall
team is in place to undertake the task.
A product recall team comprises the following members:
1. Name – General Manager
2. Name – Quality manager
3. Name – Finance /Accounts Manager/Store Incharge
4. Name– Production Manager
5. Name– Sales Representative

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The procedure followed for product recall shall be as follows:

i. Batch No and date of manufacturing can be known with the coding on the packet.
ii. From the stock transfer advice it is known to which hub that batch code material has gone.
iii. From hub it can be traced out that particular batch code material has gone to which WD (Wholesale Dealer) /
C&F (Clearing and Forwarding).
iv. From WD / C&F through bills, it is known that to which retailer/shops this material has been sold out.
REFERENCE: Appendix -25 Details of the of the product Recall/ Withdrawal is in FID/QA/039 (Mock
Recall)
Add FSSAI format
16 WAREHOUSING
Warehouse Facilities are well organized,

Clean Dry& Protected from Dust, Condensation, Fumes, Odors, Pests or other sources of contamination.
16.2 Warehousing Requirements
PRODUCT STORAGE CONDITIONS
•Product is stored under optimal conditions in accordance with the product specification.
•Factors for consideration.
–Temperature, Humidity, Exposure to light, controlled atmosphere.
PRODUCT PROTECTION
• Rejected and Accepted material is segregated.

•chemicals are Isolated from raw materials, in process product and finished product.
Ex: Cleaning materials, Lubricants.
STOCK CONTROL
•Effective stock control systems is in place.

•The total supply chain freshness control and waste control mechanisms are highly reliant on
effective Stock control at each point in the chain.
•Link stock control with logistic within a traceability system.
STOCK CONTROL PRINCIPLES

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FIFO= First in First Out

•Internal system to ensure raw materials are used ‘in sequence’
16.3 Vehicles, Conveyances and Containers
•Product is transported under optimal conditions.

•Vehicles and containers checked for good state of repair and cleanliness.
•Vehicles and containers are protected to avoid damage or contamination.
• Transportation will be carried out by Understanding the environmental conditions with responsibility.
•Vehicle and container inspection systems are in place prior to loading consignments of products
•Recording vehicle inspection report for the traceability system.
BULK STORAGE CONTAINERS
•Products are stored in bulk i.e. drums, barrel and silos.
•Bulk storage containers are having proper shelter & top covers
•Bulk storage containers will always have clear identification of contents.
STORAGE AND DISTRIBUTION
•Systems and procedures are in place during production to ensure the safety and quality of
product. Control during storage and distribution is essential to maintain this safety and quality.
•Good storage and distribution systems can significantly reduce waste throughout the supply chain.
17 PRODUCT INFORMATION/CONSUMER AWARENESS
17 Product Information and Consumer Awareness
Information for Consumers

•The finished product labeling is clear and concise and meet the regulatory requirements of the
country where the product is sold.
•Typical requirements are

–the correct name of the food
–conditions of storage
–instructions for usage
–nutritional information
–shelf life

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–Traceability information – batch code

- MRP , Per unit gram cost
-Allergen information’s
- Packing and Use by/Expiry date
Labeling Control
•The information has legal requirements which will differ from country to country
•The information must be coordinated with finished product specifications
•Label control within the factory is important to ensure the correct label is used on the product
–line change management
–the correct identification of product at all times
–records
–batch coding
Reference: All the detail will be available in appropriate product manual of particular product category.
18 FOOD DEFENCE, FOOD FRAUD PREVENTION, BIOVIGILANCE AND BIOTERRORISM

Food security involves preventing, minimizing, or responding to the deliberate contamination of food products by
a variety of potential threat agents (biological, chemical, radiological) and also potential vulnerabilities. These are
criminal actions that involve willful intent to do harm; they cannot be anticipated without intelligence
information. The motivation for these illegal actions includes the ability to cause illness and deaths following
consumption of adulterated products and the desire to cause economic and psychological damage, including
inspiring fear among the public and loss of confidence in the safety of the food supply.
Objective: To prevent any circumstance which will lead cause potential damage to food, by means of control at
different level of food chain starting from Receiving of Raw material to Dispatch of Finished goods?
Food security shall cover following SEC.s/areas.
A. Facility security:
1. Physical security: Facility shall be surrounded by continuous security fence/brick wall perimeter. Facility
premises shall be monitored by using appropriate methods like security patrols. There shall be adequate lighting
including emergency lighting, where appropriate, to facilitate detection of suspicious activities. Food items shall
be stored inside the facility or within secure compound.
2. Laboratory Safety: Entry in the laboratory shall be restricted to authorized persons only; appropriate
sign/massage for the same should be there at the lab entry. Laboratory chemicals shall be restricted to laboratory
only. Disposition of Laboratory Culture media shall be done using appropriate methods. Cleaning chemicals shall
be labeled properly and shall be stored separately from food storage area.

Effective date :
signatory below
Issue No. :0
B. Employee Security:
While recruiting the staff background examination shall be done by obtaining or verifying work references,
Addresses, Phone numbers etc. All the staff shall be provided with Photo ID cards,
Uniforms or any other things required for the work allocated and be recollected when particular member is no
longer associated with Organization.
In the sensitive areas there shall be restricted access to staff members and shall be only during appropriate work
hours.
Personal belongings shall be stored and restricted to allocated area which shall be away from storage area of raw
material, packaging material or finished products.
Food security Training shall be given to all the staff members once in six months. The same shall include
information on prevention or detection of tempering, food security awareness or other criminal or terrorist
actions.
C. Operation related security:
1. Operations: Where ever possible all the incoming material including RM, PM, Chemicals, labels etc.
shall be sourced from approved vendors. Vendor audits shall be done at once in a three year to ensure compliance
of Food security. All the incoming material shall have proper identification along with codes and expiry details.
All the incoming material shall go through quality check including quantity, quality, tempering contamination,
damage etc. Suspected material should be rejected and be taken care of as per the procedure. All the incoming
material shall be stored at appropriate storage conditions under strict dedicated supervision. Accountability for all
the material shall be established with respect to Raw material, packing material and Finished products. All the
material in storage area shall have proper identification, code, expiry detail etc.
Where ever possible product shall be packed in temper proof packing or in manner where tempering shall be
easily detected. Finished product shall be tested as per legal norms where ever required and also be checked for
tempering or other malicious, criminal or terrorist actions.
1. Water and Utility: where ever possible water storages shall be secured. Only authorized employees shall
handle the sensitive operations like control of airflow, water, electricity and refrigeration. Alternate
approved source shall be identified for water in case of emergency.
D. Access to Computer Systems
Access to the computer process control systems and critical data systems shall be restricted to only authorize
staff members. Virus protection system shall be reviewed for its adequacy and procedure shall be in place for
backing up of critical data systems or computers.

Effective date :
signatory below
Issue No. :0
The security plan is prepared to encounter mainly two concerns or security threats to food products or process
plant.
- External
- Internal
The agents that pose threat to food security are identified and listed as below.
Internal External
Facility Organized terrorist or activist groups
Disgruntled employee Truck drivers (shipping and receiving)
Cleaning crew Internally
Contractors Suspect suppliers
Temporary employees Visitors
External Factors: To counter with threat from external factors plant has taken necessary
Steps which are outlined below.
- All visitors to the plant i.e. any person not registered as staff/contract-labor, management, is screened
and given an identification badge (visitor badge) along with a record of the purpose of visit.
- Each in-coming material is verified and recorded at the security check point and before receipts of
RM/PM from approved/old vendors; the relevant documents are verified by the store manager. For
receipts from new vendors, the relevant documents are verified by Security and Purchase prior to
unloading.
- Entry of each out-going material is made at the security check point and permission for the said
movement is granted only after verification of authorized signatory.
- Security personnel do a full round patrol at regular intervals (guards in the night shift are provided
with a torch).
- Security contractor has been informed to carry a mock security to rate the efficacy of the security
system in place.
- All the assets/property of the facility are identified and a physical record is maintained for the same.
- Emergency phone numbers are displayed in the notice board and a copy of the same kept at the
security check point.
- All the employees are going through training session at certain interval.
- All the suppliers/vendors are approved and evaluated by the procurement team at defined frequency.

Effective date :
signatory below
Issue No. :0
- All the transporters are approved and well aware about the company policy. Routine inspection
procedure of Incoming and outgoing vehicle is in place. Truck drivers are not allowed to enter the
production or any critical area.
- Recruitment process is well defined to avoid entry of suspected personnel.
Internal Factors:
- The number of entrances/exits to the facility are identified and guarded by security personnel.
- Facility is well protected with brick wall to avoid unauthorized entry in the factory premises.
- All the entrances to the facility are under constant monitoring and no person/vehicle is allowed to enter
without proper screening by the security personnel.
- The fire safety plan is in place with a routine fire drill schedule. All the employees are trained and
aware about the evacuation plan.
- Complete risk analysis of the process (machines/operations/goods handling) is carried out and the
relevant concerns get addressed on a regular basis.
- All the hazardous chemicals are segregated and stored with clear identification. And limited access to
authorized persons only.
- New employees are not given any work directly related to critical processes.
- All the Employees are under constant supervision to check effectiveness of the work assigned and
personal behavior.
- All the employees have been informed to report, any malicious activity/suspicious person in the facility
premises to their direct reporting supervisor.
19. ADDITIONAL REQUIREMENTS FSSC
a) Management of services
b) Product labeling
c) Food Defense
d) Food fraud prevention
e) Environmental monitoring
f) Management of allergen
g) Storage and Warehousing

Effective date :
signatory below
Issue No. :0
FOOD DEFENCE, FOOD FRAUD PREVENTION, BIOVIGILANCE AND BIOTERRORISM RISK

ASSESSMENT
Source Risk Risk Present control measures
Assessment
Facility Un authorized entry to person or High Facility is protected with permanent wall
vehicles which can pose food security boundary with proper security
threat arrangement.
Employee Member of terrorist group entering as High Employees are recruited with proper
recruitment new employee will be threat to Food care and as per written procedure with
security known references
Visitors Direct or indirect threat to food High Visitor’s policy, Id card to visitors, entry
products/raw materials or process by only after concerning to person to be
biological/physical or chemical means. visited.
Water Contamination of water by means of High Supplier evaluation and constant check
supply & Chemical or Biological agents on receiving. Main water storage tank is
storage always under locked condition.
Responsibility of the same has been
assigned.
Internal staff Dissatisfied/Unhappy employee can High Proper training, constant check on
adulterate/contaminate product to personal behavior of the staff.
unacceptable level.
Suppliers Contamination or adulteration of the Moderate Approved vendor selection process,
Raw material leading to food safety risk Vendor evaluation at certain frequencies.
Vendor training.
Contractors Direct or indirect threat to food Moderate AMCs for most of the
products/raw materials or process by machines/services. Approved
biological/physical or chemical means. contractors. Supervision while working.
Mails Biological or chemical risk to persons, Moderate Strict security check, Responsibility
products assigned
Transportatio Contamination or adulteration of the High Vehicle inspection for receipt as well as
n Raw material/packaging material or dispatch. Frequent instructions to
final products by physical, biological or transporter regarding the requirement.
chemical agents
laboratory Un authorized access to employees High Proper implementation of GLP.
which can pose threat food security Restricted entry.
Computer Misuse of critical data Moderate Authorized access, password protection
system etc.
Reference :
Appendix -26 Potentially Sensitive Areas - FID/QA/057
Appendix -27 Food Defense Self-Assessment – FID/QA/57-A1
Appendix-32 Threat and Vulnerability assessment- FID/QA/57-A2

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General Document not to circulate and copy

STANDARD OPERATING PROCEDURE Document No. : /QA/0

Prepared by Approved by Authorized by

Asst. QA Manager QA Manager General Manager

From Dr Manoj Gandhi

PRP SEC. Revision Title Page No.

03 00 Terms and Definitions 5-7

04 00 Construction and layout of Buildings 7-8

05 00 Layout of Premises and Workspace 8-10

06 00 Utilities – Air, Water and Energy 11-13

07 00 Waste Disposal 14-15

08 00 Equipment Suitability, Cleaning, Maintenance & Calibration 16-18

09 00 Management of purchase material and supplies

From Dr Manoj Gandhi

Appendix 03 – List of authorized personnel to enter sensitive area.

From Dr Manoj Gandhi

From Dr Manoj Gandhi

This technical specification specifies detailed requirements to be specifically considered in relation to

1. Construction and layout of buildings and associated buildings

From Dr Manoj Gandhi

3. TERMS AND DEFINITIONS

3.1 Contamination: Introduction or occurrence of contaminant in food or food environment.

3.7 Material Specification (Product Specification): Detailed documented description or enumeration of

From Dr Manoj Gandhi

3.12 Sanitizing : The process of cleaning followed by disinfection.

From Dr Manoj Gandhi

4. CONSTRUCTION AND LAYOUT OF BUILDING

4.1 General Requirements:

4.3 Location of Establishments:

5. LAYOUT OF PREMISES AND WORKSPACE

5.1 General Requirements:

5.2 Internal Design, layout and Traffic Patterns:

From Dr Manoj Gandhi

• Storage of Finished Products

5.4 Location of Equipment’s

5.5 Laboratory Facilities

5.6 Temporary or Mobile Premises

From Dr Manoj Gandhi

From Dr Manoj Gandhi

6. UITILITIES – AIR, WATER AND ENERGY

6.1 General Requirements:

Drinking purpose Control measures would include –

From Dr Manoj Gandhi

1. Turbidity for visually Daily and weekly by turbidity meter

6.3 Boiler Chemicals –

6.4 Air quality and Ventilation

6.5 Compressed air and other gases

From Dr Manoj Gandhi

Reference: Appendix -8 Water layout –FID/QA/54:A:03.5

From Dr Manoj Gandhi

7.1 General Requirements

7.3 Waste management and removal:

From Dr Manoj Gandhi

7.3 Drains and Drainage

From Dr Manoj Gandhi

8 EQUIPMENT SUITABILITY, CLEANING AND MAINTENANCE

8.1 General Requirements:

8.5 Cleaning plant, utensils and equipment’s:

From Dr Manoj Gandhi