TITLE: SOP For Prerequisite

Program (PRPs)

ABC Limited has established and shall maintain the infrastructure needed to achieve conformity to the food safety
needs including as applicable.

1. Construction and Lay-out, of buildings

2. Lay out of premises and work space

3. Utilities – air, water , Energy

4. Waste disposal

5. Equipment suitability, cleaning and maintenance.

6. Management of purchased material

7. Measures for prevention of cross contamination

8. Cleaning and sanitizing

9. Pest control

10. Personnel hygiene and employee facilities

11. Rework

12. Product recall procedure

13. Warehousing

14. Product information / consumer awareness

15. Food defiance, biovigilance and bioterrorism

 TITLE: SOP For Prerequisite
Program (PRPs)

1.0 - Construction and Lay-out, of buildings:

Plant building are designed constructed and maintained keeping in view the food safety hazards elimination
a) The roof are self draining without leakage
b) Drains in plant are covered
c) Floor and walls are in good repairs
d) All crevices to be maintained and gap to be filled.

The plant is protected and closed with full access control to avoid potential cross contamination of product ,
window, glass film cover tube light covered , employee gate entry Air curtain, Insect cuter , flaps on doors or
entry points.

The facility has site boundaries with access control on both gate the Site in maintained by regular cleaning
of road ,yards and parking areas with special attention to drainage of water.`

Ref. SOP Periodic infrastructure cleaning SOP/ PROD/012

2.0 – Layout of premises and work space:

The internal lay out of the plant is maintained to facilitate good hygiene and GMP
Raw material and finished products areas are separated physical separation for products , raw material by products
is provided.
Movement of worker personnel and visitors is controlled and form separate gates for entry

2.1 Internal structure and fitting :

➢ The process area walls and floors are in good up keep.

➢ Wet process area has proper drainage with drains covered.
➢ External opening windows exhaust fans are covered with screened.
➢ All external opening doors are fitted with door closer.

3. Utilities – Air, Water ,Energy:

3.1 Water Quality :-

Water quality standards have maintained as per the prescribed norms .Water control program will evaluate the
microbiological , chemical and physical quality of source and the plant water & this includes the steam supply ,
cooling media water .
a) Hot and cold water should used in food processing , handling and storage areas and should provided at
adequate temperature and in process and in quality sufficient for all operational and cleanup needs .
b) Microbiological testing of water should be done on a monthly basis. Record of water portability testing
are maintained.
c) Boiler treatment chemicals should be used as appropriate for their intended use .

Ref.: 1- Water/ Air & Hygiene Monitoring SOP/MICR/020

 TITLE: SOP For Prerequisite
Program (PRPs)

2- Water Analysis as per IS 10500:2012 & IS 4251

3- Microbiological estimation of air SOP/ MICR/012

3.2 Lighting:

The facility is provided with proper lighting intensity and light fixture are protected where ever lights are exposed
in products or if there is chances of cross contamination due to tube glass breakage for assure and protected we
maintain Glass breakage policy which reviewed periodically.

Ref: Glass policy SOP/PROD/007

4. Waste Disposal:

Waste is identified at different stages collected removed at designated area

Waste categorized such as process waste maintenance workshop, office stationary stored away from the process
area, control and disposal of waste are carried out under supervision of housekeeping supervision.

Ref.: SOP for disposal of waste material SOP/LAB/026

4.1 Safe disposal of effluents :

It shall be ensured the waste, sewerage , wipe dust ,all other wastages generated should be disposed in such a
manner the it is not cycled back to the plant operations in any manner .
An ETP should be made functional to process the waster before discharge to the sewerage lines and otherwise

Ref.: SOP for ETP plant operation SOP/MNT/008

5. Equipment suitability, cleaning and Maintenance:

Equipment is constructed keeping in view the mature of product and cleaning system the plant is of SS- 304 & SS
316. All the equipment used for thermal process are installed as per the product or process requirements control
and monitoring of the equipment are facilitate as per monitoring schedule.

5.1 Cleaning Plant utensils and equipments :-

Wet and dry cleaning programme is implemented and its effectiveness is reviewed as per
Ref.: Cleaning of equipment & accessory SOP/ PROD/013
 TITLE: SOP For Prerequisite
Program (PRPs)

5.2 Preventive Maintenance

The preventive maintenance program includes screens, sieves, fitter and magnets fitted in the process line

Corrective Maintenance is carried out keeping in view the running of process are not at risk contamination

Make shift repairs shall not be carried out to avoid Product safety hazards

Lubricants where this is risk of direct or indirect contact with product are of food grade ref procedure of
(Preventive &Corrective Maintenance)

Ref.: SOP for preventive maintenance SOP/INST/001

6. Management of Purchased Material :

The suppliers are selected after visiting their facility is accessing their capability of meet the food safety
requirement the conformance to specification /requirements are verified.
After assessment supplier gets approved

Ref.: Supplier performance records are maintained as per Evaluation and selection of suppliers SOP/PUR/006

7. Measures from prevention of cross contaminations:

a) Raw material section is physically separated from process and finished product area

b) Separate line for each product & dedicate hygiene section for each the line
 TITLE: SOP For Prerequisite
Program (PRPs)

c) Dedicated tool box for each line

d) Separate pallets, hand trolleys for each section.

Ref.: SOP/PROD/013

7.1 Allergen Management :

Allergen policy is in place. Product itself is under allergen category. There is separate line for the each product.
Each line has its separate equipments/ tools/ manpower/ hygiene section etc to avoid cross contamination.
Allergen is declared and maintained as per procedure of allergen management and control.
Ref.:-SOP/PROD/005

8. Cleaning and Sanitation :-

a) Plant has adequate cleaning and sanitation program in place to monitor and control all elements
in the section and maintain the appropriate records .
b) Cleaning and Sanitation program should be developed for equipment , utensils , overhead
structure , floors , walls , ceiling , drain ,lighting device , refrigeration units and anything else
influencing the safety of the food .
c) Equipment to be cleaned and sanitized as defined in a written schedule; equipment cleaned is
visually inspected as per the defined routine frequencies.

For area and equipment/ Tankers cleaning and sanitizing program specifies as follows
• Name of personnel responsible
• Chemical used
• Procedure used
• Frequency of cleaning and sanitizing
 TITLE: SOP For Prerequisite
Program (PRPs)

General housekeeping and special sanitation procedure carried out during the operation should be specified.
Effectiveness of sanitation program is monitored on a routine basis by a representative (e.g.-using microbial
swab test, visual inspection of area /equipment).
Operation begin only after all sanitation required met.

Ref.:- SOP/ PROD/004

9. Pest Control Program :
Plant has an adequate pest control program in place to monitor and control all elements in the section and
maintain the appropriate record. External doors, window or ventilation opening are designed to minimize the
entry of pests.
The name of the person responsible for the program.
• The list of chemical and method used.
• A map of bait and trap and insectcuter location.
• Frequency of treatment and inspection
• Pest survey and control records.
Adherence :-
a) Adherence of the written pest control program should monitor and recorded.
b) Effectiveness of pest control program verified by an site inspection of areas for the presence of
insect and rodent activity.
c) Records of monitored results, recommendations and actions taken should maintain.

Ref.:- SOP/LAB/027

10 .Personal hygiene and employee facility

1. Facilities have provided adequate number of hand washing drying and hand sanitizing facility
including wash basin soap, Hand dryers and sanitizer equipped with sensor based taps
2. Adequate toilets with hand washing drying and sanitizing provided.
Ongoing training in personnel hygiene and handling of food is provided to every food handler and
 TITLE: SOP For Prerequisite
Program (PRPs)

Training in personnel hygiene is provided to all persons entering food handling areas.
All person working in food handling area should maintain personnel cleanliness while on duty.

Ref. SOP/PROD/004 ( SOP for Hygiene & sanitization process)

10.1 Work wear and protective clothing

Protecting clothes, hair cover and footwear, functional to operation in which employee is engaged.

10.2 Health Status:

All New employee and regular employee shall be medically examined for infectious diseases.
No needs would be allowed in food processing area known to be suffered form or known to be a carrier
of disease likely to be transmitted through food or affected with infested wounds , skin infection ,sores
is not permitted to work in any food handing area .
Person having open cut or wound do not handle food or food contact surface unless the injury is
completely protected by a secure, water proof covering.
Smoking , eating ,chewing tobacco not permitted in the company premises

Ref. SOP/PROD/004 ( SOP for Hygiene & sanitization process)

11- Rework :
Rework activity is defined & implemented to avoid any cross contamination & has the proper
traceability.

Ref.:- SOP /PROC/008

 TITLE: SOP For Prerequisite
Program (PRPs)

12.Product Recall :
The system is in place to ensure that failing to meet required food safety standard can be identified located and
removed from the supply chain.
Mock recall (Drill) are in practice as per the defined frequency
Ref.:- SOP/LAB/025 ( Product Recall)

13. Ware Housing :

All materials are stored in clean dry well ventilated storage area, temperature, humidity control is provided where
required by product or storage specification.
Waste materials are stored at designated scrap yard which is away from process area.
Chemical, and lubricants are stored at designated area.

14. Product Information :

As the product is supplied in bulk container are limited to the primary customer, all information related to
product are mentioned in COA and written on bags i.e. Batch No., Mfg Date, Quantity complying the printing &
labeling act requirement.

15. Food Defence, Biovigilance and Bioterrorism:

A situation whether accidental or intentional that is identified as constituting a serious or uncontrolled condition
of food with the potential to cause adverse health effect that requires urgent attention.
Procedure applied to situation where the food safety hazard (e.g.-Physical, chemicals & microbiological agents,
sabotage and bio terrorism) has been specially identified .It may also apply to situation where the food safety
hazard has not been identified but the relevant scientific information suggests a link between consumption of
food and a serious health effects.

Ref.:-SOP/ADMIN/008
TITLE: SOP For Prerequisite
Program (PRPs)