Processing and Fortification of Edible Oil, Wheat Flour and Milk
Processing and Fortification of Edible Oil, Wheat Flour and Milk
Processing and Fortification of Edible Oil, Wheat Flour and Milk
Processing and
Fortification of Edible Oil,
Wheat Flour and Milk
Copyright © 2015 Confederation of Indian Industry (CII), GAIN - Global Alliance for Improved
Nutrition. All rights reserved.
No part of this publication may be reproduced, stored in, or introduced into a retrieval system, or
transmitted in any form or by any means (electronic, mechanical, photocopying, recording or otherwise), in
part or full in any manner whatsoever, or translated into any language, without the prior written
permission of the copyright owner. CII has made every effort to ensure the accuracy of the information and
material presented in this document. Nonetheless, all information, estimates and opinions contained in this
publication are subject to change without notice, and do not constitute professional advice in any manner.
Neither CII nor any of its office bearers or analysts or employees accept or assume any responsibility or
liability in respect of the information provided herein. However, any discrepancy, error, etc. found in this
publication may please be brought to the notice of CII for appropriate correction.
Published by Confederation of Indian Industry (CII), The MantoshSondhi Centre; 23, Institutional Area,
Lodi Road, New Delhi 110003, India,
2. About GAIN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 07
3. Food Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5. Edible Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6. Milk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
7. Wheat Flour . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
02
In the preparation of this manual, the prevalent regulatory standards such as
FSSAI, especially Schedule 4 part 2, which are applicable to all food business
operators, and also sector specific requirements have been considered.
Further attempts have been made to capture the best practices implemented
in each of these industries and specific GMPs/ GHPs. It is a reflection of the
experience gained by CII through its National Awards assessment processes
and through the SDIs (Supplier Development Initiatives) by carrying out
individual projects/assessments in each of these sectors. Thus, the sector
specific GMPs/ GHPs, apart from addressing the general guidelines as
stipulated under schedule 4 part 2, also address the best practices for the
specific sectors.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 03
Normative References:
04
• Intervention refers to corrective action taken to improve the status of
an existing nutritional disorder/deficiency.
• Micronutrients (Vitamins and Minerals) are the nutrients that
are required in small amounts for adequate growth and development
of the human body. For example, Vitamin A, C, D, Calcium, Iron, etc.
• Quality Assurance (QA) is the process of planning, documenting and
agreeing on a set of guidelines that are necessary to prevent
contaminants from entering into the food product right from the
procurement of raw materials to the distribution of the finished goods.
• Quality Control (QC) refers to all activities that are designed to
determine the level of quality of the delivered food product. It involves
verification and comparison of the output to desired quality levels.
• Recommended Dietary Allowance (RDA) is the level of intake of
an essential nutrient that is adequate to meet the known need of the
nutrient for healthy humans.
• Restoration is the addition to a food of essential nutrients which are
lost during the course of processing, storage or handling, in amounts
which will result in the presence in the food of the levels of the
nutrients present before processing, storage or handling (FAO/WHO,
1994).
• Standard Operating Procedure (SOP) is a written procedure
prescribed for repetitive use as a practice in accordance with agreed
upon specifications aimed at obtaining a desired outcome.
• Supplement is a substance that adds further nutritional value to the
diet, when specific nutrients are not consumed in the required
quantities through food.
• Vehicle is the food that is the carrier of the nutrient and does not
reflect a transportation used for ferrying either raw material or a
fortified food.
• World Health Organization (WHO) is a specialized agency of the
United Nations (UN) that is involved in harmonizing health related
policies globally.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 05
About Gain 02
The Global Alliance for
Improved Nutrition (GAIN)
is an international
organization that was
launched at the UN in 2002
to tackle the human suffering caused by malnutrition.
08
Many developing countries have now introduced food fortification. GAIN is
working to strengthen and build sustainability into these programs to reach
at- risk populations.
Since its inception in 2002, GAIN has built and supported large-scale food
fortification programs in over 25 countries, fortifying staple foods and
condiments such as wheat and maize flour, salt, vegetable oil, rice as well as
soy and fish sauces. These programs today are reaching over 700 million
individuals.
GAIN further in India has been involved in building capacity and capability
in the food fortification of key commodities such as milk, edible oil and wheat
flour, with strategic partnership with industries volunteering for this noble
cause and also in close proximity with the government in identifying key
geographies and key vehicles for fortification.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 09
Food Safety 03
Safe food is a fundamental right of all citizens. Ensuring
food safety has been a challenge over the years both, for
developed and the developing countries. Among the
various factors responsible for human diseases, the food
borne diseases are emerging as a silent killer. Food-borne
disease outbreaks are defined as the occurrence of 2 or
more cases of a similar illness resulting from ingestion of a
common food or when observed number of cases of a
particular disease exceeds the expected number. These can
be confirmed when at least one causal agent is identified
or suspected based on clinical and epidemiological
information. Although most cases are generally sudden,
these diseases draw attention due to large-scale outbreaks,
investigation of which can help in initiating control
measures.
Ø
Wastage of food at our ports due to poor packaging
or lack of good transportation facilities.
12
Ø
Spoilage of perishable commodities such as milk, fruits, meat and
seafood products due to lack of cold supply chain management.
Ø
Losses of grains and other fruits and vegetables at mandis due to poor
infrastructure, unhygienic handling, storage etc.
Ø
In agriculture, production of substandard agricultural produce which
surpasses the requirements of chemical standards for chemical safety
elements such as pesticide residues due to excessive use of them,
heavy metals due to use of poor quality water or soil management.
Food Contamination
When there is a foreign object like stones, dust, metal articles or any other
undesirable material present in the food item, the food is said to be
contaminated and the undesirable materials are referred to as contaminants.
These contaminants can enter the food at any stage namely, production,
processing, storage, packaging or transportation and they may be dangerous
to consumer health. Some of the contaminants like toxins may be even
poisonous. Thus, you need to ensure that all the precautions are taken while
you process and package the food before it reaches the consumer. These
contaminants can be of various types:
Physical contaminants:
• Live insects (like cockroaches, ants, flies) or their body parts, rodents
(like rats) and their hair / droppings, glass or metal pieces, packaging
materials, bone pieces etc. USFDA defines any object larger than
7mm to 25 mm as harmful, as it can cause a significant hazard like
choking, food poisoning etc.
• These are the substances that get included in food intentionally or
unintentionally and affect the quality and/or safety of the food. These
can contaminate food at any stage of the production or supply.
• Adequate mechanisms exist, such as sifters, graders (for particle size
separation), metal detectors, magnetic separators (to remove metal
contaminants) and many other techniques to restrict their inclusion.
Implementation of GMPs is essential to ensure exclusion of foreign
substances such as Quality Assurance (QA) systems for supplier
verification, Quality Control (QC) for acceptance/rejection of raw
material, in-process inspection both on-site and off-site and finished
goods (FG) inspection.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 13
Ring found in food Iron nail found in food Dead house fly found in milk
Biological contaminants:
• Bacteria, virus, fungus, molds, worms, weevil etc., which may develop
either due to unhygienic practices of the workers in the plant, pest
infestation in the working area or due to poor infrastructure.
• During storage and processing, microorganisms may also develop in
food due to high moisture content of raw material, high relative
humidity in the air, lack of temperature control (generally
temperature in the range of 5°C-63°C is considered suitable for
microbial growth), accumulated dirt, dust and wastes.
• Food-borne illness may also be caused due to poisonous chemicals or
toxins released by certain bacteria and molds.
Chemical contaminants:
• Pesticide/Herbicide/Weedicide/Antibiotic residues etc. These chemicals
are generally used by the farmers to protect the food crops from
infestation, weed contamination, mycotoxin etc. But if these are used
beyond the prescribed limits they may accumulate in raw food and
prove toxic when consumed.
• Heavy Metals (Lead/Arsenic/Cadmium/Mercury/Nickel/Chromium/
Cobalt). These can enter the food through various routes such as
14
through water, environment, residues in chemicals such as paints,
equipment contact surfaces or through catalysts used in food
processing. Some of these heavy metals play a role in causing lung
cancer, softening of bones and can affect the metabolic functioning of
kidney, lungs, liver etc.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 15
Good Manufacturing
Practices (GMPs)
04
Good Manufacturing Practices (GMPs) in a food
plant are associated with the following factors:
G. Food processing
H. Food packaging
I. Food distribution
M. Traceability of product
D. Personal hygiene
E. Visitors
18
A. Location and Surroundings of the plant
A proper site evaluation for key environmental risks like probability of floods
in coastal areas shall be carried out before establishing a food manufacturing
facility and the plant surroundings must be kept clean.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 19
• You should inform the higher authorities if there are any damaged
roads or path ways within the plant premises so that they can be
repaired soon and the environment is free from dust.
20
Keep no open drain holes or drains Install covered drainage system
inside the plant inside the premises
• Screen the windows, doors, openings for ventilation with wire mesh,
strip curtains, air curtains, grills as suitable, to prevent the entry of
dust, cockroaches, rats, lizards, birds and stray animals like dogs.
Get all the doors and windows covered with wire mesh to prevent entry of insects and birds
Use strip curtains in processing Cover all the drain holes in the
and packaging areas premises with grill
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 21
• Check that all the overhead
fixtures like lights,
insectocuters, etc. have a
shatter-proof covering,
preferably of tempered glass
or fiber so that any broken
glass pieces or dead insects
do not fall down directly into
the food preparation and
packaging areas.
Use lights having shatter-proof covering
• See if the paint on the walls
of the plant is intact. In case
the paint is peeling off, get
the walls repainted, preferably in light colors where dirt and insects
can be easily noticed.
• Regularly check the floors, walls, windows, doors and drains for any
crack or other damage and bring this to the notice of factory manager
for faster repairs.
C. Equipment
The machines, vessels and containers used during food processing play an
important role in food safety. The maintenance and cleaning of these
equipment is of extreme importance.
• Check that all the machines and vessels used for food processing are
made of material that is non-toxic and does not get easily corroded and
hence safe for food like food grade stainless steel. Do not use corroded
or chipped containers.
22
• Get the machines installed in the plant such that there is sufficient
free space to allow easy cleaning of the machines and the surrounding
area.
• Lay the machinery in such a manner in the plant that the flow of food
material is unidirectional from procurement to processing to
packaging to warehousing and then dispatch. This will help avoid
cross-contamination of foods at different stages of processing.
• Keep the equipment used in your food plant free from dust and dirt by
regular cleaning with water, compressed air or steam.
• Clean all the machines, equipment, tools and containers used in the
food manufacture after every day’s operations so that no remains of
food are left sticking on the equipment surfaces.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 23
D. Facilities to be provided in the food manufacturing
plant:
1. Water Supply
• Ensure that there is continuous supply of safe potable water for food
processing, cleaning of equipment and hand washing purposes.
• Ensure a regular supply of water for toilets, cleaning of floors and for
fire-fighting purposes.
• Clean the water storage tanks periodically and maintain the records of
the same in a register.
2. Gas/ air supply for food processing
3. Personnel Facilities
Facilities like clean toilets, separate toilets and changing rooms for male and
female workers and other facilities for working personnel must be provided to
ensure personnel hygiene.
24
• Check that there are sufficient number of wash basins with regular
supply of potable water for washing of hands by the food handlers
along with soap and facility to dry hands like disposable paper rolls or
hand dryers.
Separate toilets for men and women workers that are clean Separate hand washing facilities
• You must check that the exhaust fans, chimneys, windows installed in
the plant are regularly dusted and cleaned on daily basis.
• Always cover the lights in shatter-proof tempered glass or fiber
coverings etc. to avoid broken glass pieces from falling into the food
during processing, in case of breakages.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 25
• You should also cover all the exhaust openings and windows with wire
mesh to avoid the entry of birds, insects and other pests.
• You should get any broken lights and exhausts repaired as soon as
possible.
Check that the vehicles are covered when they arrive with raw material to ensure no
damage due to rain or bird infestation
• You should check the raw material for any visual infestation or
microbial growth. If present, then reject the raw material immediately.
• You should always do random sampling of the raw material and test
the sample as per the internal specification before accepting the raw
material.
• You must maintain a record of all the raw materials received along
with the details of the supplier, transport vehicles, date and time of
receipt and the test results obtained from the laboratory.
26
F. Storage of Raw Material
• Always check that the storage area is clean and dry and that there are
no pests in the area.
• For perishable commodities
like fruits, vegetables, meat
products, milk etc., use the
cold storage area.
• Use separate areas for
storage of raw material,
processed foods, packaging
materials and wastes. Label
the containers and areas used
for each of them for easy Raw Material storage in Silos
identification.
• In case of meat, poultry and
sea foods, store them in separate cold storage areas to avoid cross
contamination.
• Ensure that the containers
being used in the plant for
storage of raw materials are
not toxic like gunny bags,
cartons, containers of
stainless steel etc.
• Store the raw materials at
least 2 feet away from the
walls and 4” above the
ground on pallets to allow
Use pallets to store raw naterial
easy cleaning.
above the ground
• Follow FIFO (First In, First
Out) stock rotation system i.e. the material that is received first shall
be sent out first.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 27
• Do not re-freeze any thawed food.
• Maintain a record of all time and temperature treatments and train
the workers after every few months to follow the same.
H. Food Packaging
Packaging of food is done after processing to ensure that the food does not get
re-contaminated before reaching the consumer. It ensures product safety after
production. The labelling on the packaged foods is important for conveying
product information and creating consumer awareness regarding the product
like the ingredients used, date of manufacture, “best before” date, nutritional
content etc.
• Check that the packaging material is food grade with no strong odor of
chemicals or colors.
• Do not store the packaging
material directly on the
floors. Use racks or pallets to
keep the material atleast 4”
above the ground.
• You must visually inspect the
packaging material/
containers for any visible
infestation, dead insects,
cockroaches etc. on the
surface before using them
Use pallets to store raw Clean and dedicated
and reject the infested naterial packaging area
packaging material as it will above the ground
contaminate the food.
• Use of inert gases like Nitrogen may be done to provide extra
protection to the food from oxidation or microbial growth.
• Ensure that every package has complete labelling along with
nutritional labeling as per provisions of Food Safety and Standards
Act, 2006.
• Ensure that every package of Food has the batch no. and a unique bar
code for tracing back the item in case there is a customer complaint in
future.
28
• Check the date of manufacturing, MRP, best before date, batch
number to ensure traceability of the product. Net contents and MRP
should always be mentioned on the package
• Provide nutritional information in grams or % by weight and per
serving size in decreasing order of amount of the nutrient present.
• All additives such as colors, flavors, preservatives, acidulants,
buffering agents, sequestering agents, aerating agents etc., shall be
declared along with the respective E numbers.
• There should be complete information on the label to inform the
consumer about how to handle, store, and prepare/ process the food
products safely and correctly.
• It is a good practice to provide information on any possible allergens
present in the food.
• The labels will have to be verified periodically and changed as per the
prevailing regulations.
J. Traceability of products
Traceability means the ability to
track any food, feed, food-producing
animal or substance that will be
used as an ingredient at any stage of
production, processing or
distribution with the help of records.
Bar codes, batch number, date of
manufacture are some of the tools Example of a barcode which is unique
used for this purpose. to each batch of each product
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 29
• Every individual package of any kind of food product must possess a
barcode, date of manufacture and batch number on its label which is a
unique code for identification.
• Immediately withdraw the product or a particular batch of a product,
in case of detection of any unacceptable characteristics in the quality
of the product.
30
L. Food Testing Facilities
• Ensure that the in-house laboratory has all the equipment and
chemicals you need for testing of raw materials, in-process foods and
finished products.
• The laboratory staff must be competent and trained to understand and
assess the quality control parameters during food sample testing.
• If you do not have the facility to test a parameter then send the
samples to an NABL accredited laboratory outside.
• You must also send the finished goods for testing to an NABL
accredited laboratory periodically.
• Keep a separate space for keeping the retention samples in the
manufacturing plant.
• Maintain signed records of all the tests conducted in the laboratory.
M. Audits
• You should conduct internal audits/ checks in the plant at regular
intervals to improve GMPs and GHP’s in the production, process and
the product quality.
N. Training
Personnel, especially the food handlers, need to be trained on GMPs and
GHPs so that they follow these practices while working in the manufacturing
and storage areas to ensure food safety.
• Instruct the food handlers and train them regarding food hygiene and
food safety aspects.
• You must conduct a compulsory training on GMPs and GHPs for every
new employee.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 31
• Conduct periodic assessments of the effectiveness of training to ensure
that food hygiene and food safety procedures are being carried out
effectively.
• Also conduct periodic skill assessment of the employees by way of
questionnaire, quiz, discussion and reviews.
• COP is when you dismantle the equipment and wash the dismantled
equipment and machine parts in a central washing area and put them
back together in the respective locations after cleaning and drying.
32
• You must follow a schedule of cleaning the premises which shall
include:
• Place to be cleaned
• When to do the cleaning?
• Who will do the cleaning?
• How the cleaning should be done?
• Clean the freezer units, refrigeration units, filters used in the
machines, vessels, containers, equipment and all food contact surfaces.
• Regularly carry out the preventive maintenance checks of machinery,
building and facilities to prevent breakdowns.
• Lubricate the machinery periodically to ensure smooth running of the
machines. Use only food grade lubricants for this purpose.
• In case of spillage or food left overs, immediately clean the working
station, floor or equipment.
• Handle the cleaning chemicals as per the instructions given on the
MSDS (Material Safety Data Sheet)
• Store these cleaning chemicals in a separate dedicated area away from
food items to avoid any cross contamination.
• Keep a record of all the cleaning activities conducted.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 33
Signs of pest infestation
• Rats – can be detected if you find any droppings, holes,
runways, gnawing marks, feet marks and smears.
• Cockroaches – Hide behind stoves, hot water pipes, sinks,
cupboards, cracks and crevices, broken tiles. Signs- eggs,
droppings and disagreeable odor.
• Flies infest places with food attraction. Signs – Fecal specks
and vomitus.
• Lizards – Hide behind switchboards, wall panels. Signs –
Droppings.
You must maintain a pest sighting record.
? 1-Deny Entry
• Seal all holes, cracks on ceilings,
walls and floors.
• Use double doors / air curtains /
strip curtains at entrances.
• Cover the windows, drain holes and
any other openings with wire mesh
and metal grills.
• Control the entry of animals, birds,
and pets.
? 2-Deny Shelter
• Clean all the places where pest may live.
• Avoid false sealing in storage and processing areas.
• Repair any cracks and holes on walls, floors, ceilings,
corners, doors and windows.
• Throw away any unwanted articles like damaged tyres,
scrap etc.
• Eliminate potential pest breeding sites like stagnant water,
scrap or open food wastes.
• Do not allow water to accumulate in open area within the
factory.
• Clean the wire mesh on windows and exhausts regularly to
remove the accumulated food dust and dirt.
34
? 3- Deny Food
• Eliminate food sources to pests
• Store all food materials in sealed /
covered containers.
• Floor shall be free from any food
wastes.
• Store, process and package the Do not scatter food in order
food only in dedicated areas. to avoid pests feeding on them.
? 4- Deny survival
• Clean & disinfect pest infested places, clothing and
equipment.
• Use insectocutors to get rid of any pests within the factory.
• Place the insectocutors 4.5 to 6 m
away from food handling area.
• Clean insectocutors every week.
• Cover all foods during spraying of
pesticides.
• Use glue pads or traps for rodents Use insectocutors to get rid of
like rats. any pests within the factory
• Screen the windows, doors, openings for ventilation with wire mesh, strip
curtains, air curtains, grills as suitable to prevent the entry of dust,
cockroaches, rats, lizards, birds and stray animals like dogs.
• Use glue pads, rodent traps, Insectocutors to limit the entry of and to
eliminate any pests or rodents present in the premises.
• Use licensed agency for the pesticide and insecticide sprays in the food plant
periodically to kill the pests. You should spray the chemical in the
manufacturing area only after the production operation has finished. Keep a
record of these pesticide applications.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 35
E. Drainage and waste disposal
• Check that your drainage system is functional at all times to avoid any
water logging in the manufacturing plant.
• Clean all the drains periodically to avoid accumulation of waste/ dirt
and pest harborage. Maintain
records of cleaning.
• Ensure that all the drain
openings are screened with
metal grills or mesh to avoid
accumulation of waste.
• Do not let the waste
generated accumulate in the
food processing or packaging
areas and immediately collect
the wastes in covered
containers and store them Covered drains inside the
away from the food handling premises to avoid any water logging
areas.
• Dispose off the collected waste at regular intervals so that it does not
generate bad odor in the area or lead to microbial growth.
• Ensure that the plastic/metal/ glass materials are disposed of in an
environment friendly manner.
• Collect the dry and wet
wastes separately and
segregate the biodegradable,
non-biodegradable and
recyclable wastes.
• See that there are sufficient
covered dustbins in all the
areas and that no waste is
left lying in the open. Separate and labeled containers
for different types of wastes
• Clean, disinfect and dry all
the dustbins before next use.
• Conduct regular health checkup of all the food handlers (at least once
in a year) by a registered doctor to detect any infectious, contagious or
other communicable disease.
36
• Do not allow any person suffering from any disease to enter into the
food handling area as he/she may contaminate the food and/or spread
the infection among other workers.
• Maintain a record of illness of all the workers and their health
checkups for future reference.
• In case of an epidemic, vaccinate all the food handlers.
• Ensure that every food handler wears clean clothes, face mask, hair
net, hand gloves, shoe cover/ clean foot wears in the food handling
areas on a daily basis.
• Do not let workers with open wounds or cuts handle the food items.
Dress the wounds and cuts with clean bandage every time before
handling food or food contact surfaces.
Open wounds
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 37
• Do not allow the workers to rest or eat within the food handling areas.
Instruct them to use the designated areas for the same.
• Motivate the workers to
follow hand hygiene practices
like:
- Wash hands with soap
and water every time
after they use toilet or
touch their mobile
phones, doors or after
scratching, sneezing,
coughing or pricking
their nose.
- Dry their hands every Hand Hygiene Practices
time after washing with a
hand dryer or a disposable paper napkin. Sanitize their hands
before they handle food or food contact surfaces.
- Cut their nails short and not to use nail paints.
- Wear gloves during handling the food materials.
38
See how washing of hands with soap and sanitizing with
sanitizer reduces germs on your hands
G. Visitors
There could be external personnel like customers, suppliers, government
officials, senior personnel from the organization, students etc. who can visit
the manufacturing area. The following practices need to be followed by the
visitors to avoid any cross contamination.
1. Take down the visitor details like name, contact address, purpose of
visit, time and date of visit along with the visitor’s signature before
you allow him/ her inside the plant premises.
2. Provide the visitor with face mask, hair net, hand gloves, shoe cover
before entering the manufacturing premises.
3. Do not allow the visitor to physically touch the food being processed.
4. Take a declaration and verify from the visitor that they are not
suffering from any infectious disease or have any cuts or wound.
5. Accompany the visitor at all points.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 39
Checklist for Infrastructure and Layout of a food
manufacturing plant
S.No. Good Practices YES (Y)/
NO(N)
3. Is the residential area for employees located away from the food
manufacturing area?
4. Are the walls and floors of the food manufacturing plant made of
permanent material that is non-toxic and non-absorbent?
6. Are all the equipment and machines installed in the plant made of
non-toxic and non-corrosive material?
4. Have you reported the higher authority for any damaged roads or
pathways?
2. Are all the doors, windows and drain holes screened with mire
mesh or grill?
EQUIPMENT MAINTENANCE
40
S.No. YES (Y)/
NO(N)
4. Do you clean the machines and vessels after every day’s operations?
6. Have you labelled all the containers and equipment for easy
identification?
3. Is the air supply free from odor, dust, moisture and grease?
8. Is there a hand washing and drying facility available for the workers?
10. Are the workers provided with hand gloves, uniforms, face masks,
shoe covers, hair nets etc.?
3. Did you collect random samples of the raw material for testing?
5. Have you maintained records for all incoming raw material, supplier
details and testing results?
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 41
S.No. YES (Y)/
NO(N)
3. Do you store the raw material at least on pallets at-least” above the
ground and 2 ft. away from the walls?
1. Do you have specified time and temperature controls for food processing?
2. Do you have a ventilation system to vent out the smoke from food
preparation areas?
FOOD PACKAGING
FOOD DISTRIBUTION
4. Do you store all foods at least 4” above the ground and 2 ft. Away
from the walls?
6. Do you check the vehicle for any pest or dirt before loading them?
42
S.No. YES (Y)/
NO(N)
AUDITS
TRAINING
1. Are there regular trainings for food handlers on food safety and
good hygiene practices?
2. Do you regularly clean the refrigerators and filters used along with
the vessels and containers?
1. Have you got all the cracks and holes in the walls and floors
filled/ repaired?
2. Have you screened all the windows, doors, drains, drain holes,
exhaust openings etc. with wire mesh/ grills as suitable?
3. Have you eliminated any potential pest breeding sites like pot
holes, garbage dumps etc.?
7. Do you spray the pest control chemicals only after the day’s
operations are over or after covering all the foods and equipment?
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 43
S.No. YES (Y)/
NO(N)
4. Do you separate the plastic, glass, metal wastes etc. from the
food wastes?
PERSONNEL HYGIENE
1. Are there regular health checkups conducted for the food handlers
by a registered doctor?
3. Do all the workers wear clean uniform, hand gloves, hair nets,
face masks and shoe covers during food handling operations?
4. Do you check that workers with any open wounds or cuts do not
handle the food or the equipment?
5. Do the workers always wash and dry their hands before handling
food items?
VISITORS
2. Do you provide the visitors with hand gloves, face masks, hair nets,
and shoe covers before entering the food manufacturing area?
3. Do you accompany the visitors at all points and not allow them to
touch the food being processed?
44
Edible Oil 05
Content
B. Procurement Norms
C. Storage Norms
D. Processing Norms
2. Oil Extraction
3. Refining
4. Fortification
E. Packaging Norms
3. Equipment Maintenance
7. Personnel Hygiene
46
A. Process Flow Diagram (Edible oil Processing)
Oil seeds
Not approved
Incoming Reject
inspection
(QA check)
Approved
Storage
Cleaning
Conditioning and
Pretreatment
Conditioning
Dehulling
Oil Expelling
Filtration
Degumming/
Dewaxing
Neutralization
Bleaching earth + Activated Carbon
Bleaching
Spent Earth Refining of Oil
Deodorization
Antioxidant addition
Primary packaging
Filtration material
Not
approved Approved
Quality Fortification Testing for Packaging
testing vitamins
Approved
Not approved
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 47
B. Procurement Norms
When you receive the oil seeds in gunny bags or in bulk, take a random
sample from each batch/ vehicle of seeds and send it for quality check by the
QA/QC department. Unload the raw material at a clean and hygienic
unloading station.
• Sampling
Collect a random sample from various gunny bags based on the sampling plan
below. From this composite sample, make a small sample of 2 kg. Use 1 kg of
this sample for testing and another 1 kg should be stored by the QC as a
retention sample.
Up to 50 5 8
51-100 8 13
101-150 13 20
151-300 20 32
(Reference: IS 4115)
• Testing
The incoming grains are tested for moisture, foreign matter, infestation and
damaged seeds. Label the retention sample with vehicle number, inward gate
pass number, number of bags, total weight, date of receipt, supplier details,
product name and internal QC code.
• Record keeping
48
Sample format for incoming inspection record
Receiving Logs
C. Storage Norms
• Store the oil seeds in clean
gunny bags or large silos
made of stainless steel/
aluminum.
• Store the oil seeds at ambient
temperature.
• Ensure adequate ventilation
in the oil seeds storage area.
• Store the oil seed gunny bags
and packaging material at
least 2 feet away from the Use pallets to store raw material above
walls and 4” above the the ground
ground on pallets to allow
easy cleaning.
• Store the cleaning agents, packaging materials and process chemicals
separately and label these storage areas to avoid any confusion.
• You must follow the FIFO (First in, first out) system of stock rotation.
D. Process Norms
1. Cleaning and Pre-treatment
Clean the oil seeds by passing through sieves, sifters, de-stoners to remove all
the dirt, stones, weeds and other extraneous matter and then leave them for
conditioning/cooking before the seeds are flaked and used for oil extraction.
• Ensure that the conveyor belts carrying oil seeds from the storage area
to the conditioning vessels are clean and dry.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 49
• Clean all the equipment, including de-stoners, sieves, hullers etc.
periodically, typically every 4 hours to remove any small particles of
oil seeds or their husk and flakes, if present.
• Ensure that the cleaning unit (including conveyor system, de-stoners,
aspirators, sifters and hullers), flaking unit and milling/cracking unit
are dry at all times with zero moisture.
• Use only potable soft water for cooking/conditioning of oil seeds.
• Lubricate the machines periodically with food grade lubricants for
smooth functioning.
Hulls removed
2. Oil extraction
Two major methods used in the edible oil industry for extraction of oil from
the oil seeds are:
a) Mechanical pressing
The oil is extracted from the conditioned oil seeds mechanically by a
hydraulic press. The method has relatively low yield or oil recovery and is
generally used for oil rich seeds like sesame and ground nuts. The oil may
be used directly after filtration.
b) Solvent Extraction
The oil is extracted from the conditioned oil flakes by a solvent medium
i.e. n-hexane. This method has a higher yield or oil recovery and is widely
used commercially in combination with mechanical pressing to recover
maximum oil possible from the seeds.
50
• Ensure that the oil extraction machinery and container are not
corroded and made of non-toxic material like stainless steel.
• Check the valves and pipelines for any blockage or leakages to avoid
carryover of n-hexane or miscella into crude oil.
• Maintain uniform flow rate in the de-solventizer to obtain better
output during solvent extraction.
• Test the crude oil obtained at the end of extraction process. It should
not contain traces of hexane which can be poisonous if consumed.
• Always keep fire-extinguishers ready in the solvent extraction unit as
n-hexane is highly inflammable.
Oii Extraction
De-oil cakes
3. Refining
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 51
a) free fatty acid content
b) Color
c) Odor/flavor/Sensory
d) Gum content
3. Monitor the free fatty acid content every 2 hours. You should monitor the
dosage of citric acid.
• The spent earth obtained after the bleaching process is inflammable and
must be cooled immediately.
• The spent earth must be collected in an open area and sprinkled with cold
water to cool it down.
6. Test the refined oil for quality in laboratory after every shift.
Fortification is the process of adding vitamin premixes with edible oil in a controlled
manner. It is a two-step process:
52
Preparation of pre-blend for 5 MT of refined oil:
Gradually pour this pre-mix into 5L refined oil in a stainless steel container
Stir continuously for 10-15 minutes with a clean stainless steel rod
Rinse the pre-mix bottle at least three times with the oil
Pour the pre-blend into the blending tank for circulation and mixing.
The mixing of pre-blend with refined oil can be done either by batch mixing
process or by continuous mixing method.
VITAMIN A & D
Refined FORTIFICANT
Oil From
Factory
Fortification
Tank Storage or
Premix Prepack Tank
Blending Packaging
Tank Area for
Small & Large
Volumes
PUMP PUMP
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 53
Continuous Mixing Process:
Vitamin A & D
TBHQ Fortificant
Micro
Micro Dozer
Dozer
Pump Pump
Fortification
Tank Storage or
Refined
5-10Metres Prepack
Oil From
Tank
Factory
Inlet Valves
Outlet Pump
Valve
Packaging
Area For Small
& LargeVolumes
54
• Maintain a constant flow rate of pre-mix blend into the oil to ensure
homogenized mixing.
• In continuous mixing process, place the micro dozer 5-10 meters before
ahead of the refined oil day tank to ensure efficient mixing.
• In batch mixing process, fix the blender close to the bottom of the
blending tank to minimize the mixing of air into the oil.
• Test the fortified oil periodically (every shift) by the violet ring test
which is a qualitative test that confirms that vitamin A is present in
the oil.
E. Packaging Norms
Packaging process involves setting up primary packaging material, filling of
fortified edible oil, sealing and
packing in primary and then
secondary containers.
1. U s e o n l y f o o d g r a d e
packaging material as per the
industry standards.
2. Check that the primary
packaging material is free
from foreign matter like dust,
threads, plastic pieces, paper,
off odor and pests. Collect the finished product packets in clean
boxes/ containers
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 55
3. Keep floors of the packaging section dry and clean.
4. In case oil is spilled, immediately clean the surface to maintain
cleanliness and avoid accumulation of dust and dirt.
Organized Storage on
warehousing pallets
1. The warehousing area must be maintained clean and dry at all times.
It should be well lighted and ventilated with adequate number of
lights, windows and exhaust vents.
2. Store the packaged goods at least 18” away from the walls and 4”
above the ground on pallets and never allow the goods to lie directly on
the ground.
3. Ensure from time-to-time that pest control equipment like pesto-
flashes, rodent boxes and glue pads are in working condition.
4. Look for any sign of pest activity in the warehouse and immediately
inform the warehouse manager.
5. Ensure that a system of FIFO (First In First out) is followed during
dispatch. The early manufactured goods must be dispatched first.
56
6. You must inspect the transport vehicles before loading them for any
foreign matter like rusted surface, dirt, pests or weevils, moisture and
any strong smell.
7. Load the finished goods in
enclosed trucks. If the vehicle
is open from the top and/or
sides, then cover the
transport vehicle from all the
sides with preferably a water
proof material like tarpaulin
sheet to protect the finished
goods.
8. Cushion the vehicles with dry Bulk oil stainless transport
grass before loading the retail tanker vehicles- air-tight steel tankers
packages to avoid physical with no corrosion
• The edible oil plant should not be located in areas with high risk of
floods.
• You should always check that the plant premise is free from stagnant
water, scattered garbage and scrap to maintain the plant
surroundings pest free and hygienic.
• You should have residential areas away from the manufacturing area.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 57
• You must report any pest sighting in the surrounding areas like
insects, rats, snakes, animals, birds etc. immediately to the factory
manager and take all possible preventive steps for pest control.
• Walls and floors of the raw material storage area, production and
packaging section and the warehouse should be well maintained
without any cracks or holes to prevent rodents like rats, cockroaches,
etc. from hiding and to prevent dirt from accumulating.
• Leave free space in between and around the machines especially in the
packaging section to allow easy movement and cleaning.
• It is preferable that the walls and floor should be of light color so that
any pests or dirt can be easily seen and cleaned.
• Cover the lights on the walls and ceilings with shatter-proof plastic/
fiber covering to prevent broken glass pieces from falling into the
processing area.
• Get all the windows screened with wire mesh and the drain holes
covered with metal grills to prevent pests from entering the processing
area. Clean the dirt and food dust from these wire mesh and grills
every day.
• Place air curtains or strip curtains on the doors/ entrances to prevent
entry of pests and dust/ dirt from outside.
• Warehouses should have proper ventilation and illumination. See that
there are adequate lights and windows/ exhausts for the same.
Covered lights.
Labelled equipment
58
• You should periodically check that the equipment and containers are
not damaged (corroded, rusted, broken) to avoid metal particles
chipping off and entering the product stream.
• Place the equipment in the processing areas with sufficient free space
such that they are easy to clean and maintain.
• Label the equipment and mark the pipelines (color coding) for easy
identification.
• You should label the vessels/ containers used for storage of wastes and
by-products (Sooji, Maida etc.) for easy identification.
• Always cover all vessels and containers containing flour with a proper
fitting cover/lid to protect the wheat flour completely from dust, dirt
and flies and other insects as well as air.
• Check the machines regularly. For e.g.
Ø
all steam supply valves and steam traps for leakage
Ø
weighing equipment and temperature gauges for errors
Ø
all oil pumps and pipelines for leakage
Ø
equipment calibration
• You must cover all the openings of the drains with metal grills to avoid
garbage from entering the drains leading to blockage and also to
prevent entry of insects and rodents.
• Keep a check that the waste generated like stones, extraneous matter,
spilled oil etc. is stored away from the raw material storage or food
processing areas and in covered containers.
• You must dispose off the waste/scrap periodically to avoid
accumulation and breeding of
pests.
• The waste generated shall
not be disposed into the open
areas outside the factory, on
roads or into the drains to
avoid environmental
contamination. You must
ensure that the waste
disposal is carried in eco- Separate and labeled containers
friendly manner at for different types of wastes
designated sites.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 59
• Place waste collection bins in all the manufacturing sections of the
plant for efficient collection of waste. Number of bins should be based
on the average amount of waste generated in that particular area.
• Different kind of wastes like paper, food waste, plastic waste and hazardous
waste can be collected separately for easy disposal.
60
6. Pest Control System
Pests like rats, cockroaches, worms, lizards and their droppings, feathers or
wings of birds etc. are a common source of contamination in the plant and
should be prevented from entering the premises to ensure food safety.
• You must keep a check for any rats, cockroaches, spiders, lizards, or
stray dogs, if seen in the premises.
• Clean the spider webs on the ceilings, walls, doors, grills etc. regularly.
• Do not allow any stray animals like dogs or cats to enter the premises.
Keep the doors of the area closed for this reason.
• You can use strip curtains, air curtains to limit the entry of insects
into the working area.
• Screen the windows and exhaust/ ventilation openings with wire mesh
to control the entry of birds from outside.
• You may use glue pads, traps, insectocuters, and insecticides/
pesticides to get rid of the pests but do not forget to cover the food
items and the equipment used for oil manufacture before you spray the
chemicals in the area.
• Use the 4D system as mentioned in the general section for pest control
management.
7. Personnel Hygiene
Hygiene of the workers is important for food safety as the workers are in
direct contact with the food. It includes the cleanliness of clothes, shoes,
hands, toilets used by the workers, as well as the health of food handlers. You
must take precautions to maintain the personal hygiene.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 61
Ø
Safe potable water, soap for hand washing and hand drying facility
like hand dryers or disposable paper towels.
Ø
A facility for drying hands near the hand washing station.
Ø
A separate changing room for male and female workers to change
into clean uniforms before entering the food handling area.
Ø
A separate area/canteen for resting and eating for the workers.
• Provide the workers with uniform, disposable gloves, face masks,
hair/beard nets, and clean foot wear/shoe covers to avoid
contamination of oil during processing and packaging.
• Motivate the workers to wash hands with soap and water every time
after using toilet as well as after touching foreign objects like phones,
money, etc. or scratching of body parts, coughing and sneezing.
Provide them with hand sanitizers especially in the packaging area.
• You must ask the workers to trim their nails and not to wear any nail
paints as it may contaminate the oil.
• You should see that the workers do not wear any Jewellery or other
accessories like bangles, watches etc. during handling of wheat at any
stage. In case of religious issues like wedding rings etc., hand-gloves
must be used. Lost items must be reported.
• You should encourage the workers to wear gloves, face masks, hair
net, uniforms at all times during the operation to avoid contamination
and teach them how to dispose these masks, gloves, and hair nets. Ask
them to throw these after use in the designated bins and not in the
open.
• Do not consume alcohol, tobacco or smoke cigarette within the
processing area as it may contaminate the oil.
• Do not eat food within the premises. Use the designated canteen area
or refreshment rooms for having your lunch and tea.
• Do not spit on the walls of the building.
62
• Maintain records of these health checkups.
• In case of epidemic in your area/ city, you must get the food handlers
vaccinated.
• If suffering from any disease, the workers must inform the supervisor
and should not be allowed inside the food handling premises.
• Do not allow the workers with open cuts or wounds to handle food or
equipment.
• First aid must be available for workers in case of emergency. Maintain
a record for all first aid medicines and their consumption. Check these
records periodically.
• Provide the workers with technical training about the use of machines,
time and temperature requirements for oil manufacture at each stage,
and also the hygiene practices that they must follow, once in every 6-8
months..
• Evaluate the effectiveness of these training programs through periodic
assessment of workers by through questionnaire, quiz, discussion and
reviews.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 63
Milk 06
Content
B. Procurement Norms
C. Storage Norms
D. Process Norms
1. Homogenization
2. Standardization
3. Pasteurization
4. Fortification
E. Packaging Norms
3. Equipment Maintenance
7. Personnel Hygiene
66
A. Process Flow Diagram
Homogenization and
Standardization of Milk
Processing of Milk
Processing of Milk
into
intoVarious Products
Various Products Pasteurization of Milk
––Butter,
Butter, Ghee,
Ghee,
Paneer, Cheese,
for 15 Seconds at 72°C
Paneer, Cheese,
Butter Milk
Butter Milk
Marketing and
Distribution
B. Procurement Norms
Milk is a highly perishable commodity, it can get spoiled very easily. Thus
you must maintain strict hygiene measures while collection of milk.
• You must wear clean disposable hand gloves, shoe covers, hair nets,
face masks and uniform/apron during milk collection.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 67
• You must check the vehicles
that are used to deliver raw
milk for the presence of any
physical rusted surface,
strong odour or pest
infestation.
• Accept the raw milk only if it
is free from dirt, undesirable
micro-organisms, drugs and
toxic chemicals. Reject the
milk if you find any of these.
Personal hygiene during milk procurement-
• Accept the milk only if it clean uniform, hand gloves, face mask and
arrives to you in closed hair covers are must
containers with proper fitting
lid/cover.
• As soon as milk is received at the plant, collect random samples for
each batch of milk from different sources for quality tests, chemical as
well as microbiological.
• Conduct the Clot on Boiling
Test (COB) and Gerber’s Test
to check for the sourness as
well as the Fat and Non-fat
Solids (SNF) content of milk,
respectively.
• Test the milk sample for its
content of Coliform bacteria,
yeasts and mould.
• You should accept the milk
only if it has a minimum of
Refrigerated tanks must be kept ready at
3% Fat content and Solid Non site of procurement
Fat Content of 8.5%.
• Immediately after collection,
you must transfer the milk into reefer containers or tankers
maintained at constant temperature below 4 °C for transportation. Do
not let the temperature rise above 4 °C.
68
C. Storage Norms
Milk should always be maintained at low temperatures to avoid growth of
bacteria or other microorganisms. You must have a cold storage facility for
storing milk.
• Immediately after procurement and testing, cool the raw milk to 4°C
and maintain the temperature until processing. You can store the milk
in Silos/ Tanks made of aluminum/stainless steel.
• You must keep the containers covered/closed at all times to prevent
infestation with flies/insects.
• Mark the raw/processed/rejected/recalled milk and store them
separately.
• Where dairy products other than raw milk are stored under cool
conditions, their storage temperatures should be recorded and the
cooling rate should be adjusted in such a way that the products reach
the required temperature at the earliest.
• Always follow “First in, First out” (FIFO) system for milk processing.
D. Process Norms
1. Homogenization
Homogenization is the process that gives milk its smooth texture and fine white color.
The fat in milk normally separates from the water and collects at the top.
Homogenization breaks the fat into smaller sizes so it no longer separates. This
process employs the principle of breaking large milk molecules into smaller ones by
forcing the milk through small holes under very high pressure of 2000-3000 psi which
in some cases goes up to 14000 psi.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 69
• You must clean and disinfect the equipment and vessels after every cycle, to
ensure that no milk residues are left within the equipment where bacteria
may grow.
Casein micelles
Fat globules
Fat - casein
micelle
aggregate
Homogenization Process
This involves processing of milk and adjusting the content of fat and solid
non-fat (SNF) in the milk. This technique is important to modify milk to meet
the changing demands of the consumers.
70
3. Pasteurization
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 71
4. Fortification
1) Batch mixing- Use this method when the dairy is processing the milk
in batches of 10,000 Kg-15,000 Kg tanks. Calculate the vitamin
required according to the batch quantity and then add and agitate it
properly to get the fortification level of Vitamin A: 2000 IU/L and
Vitamin D: 400 IU/L.
Chilled Milk
Mix by Stirring
Bulk Agitation
Pasteurization
Cooling
Packaging
01
72
Standardized To Final
Product Heater
Stainless Steel
Sanitary Fitting and
Check Valve
Check Valves
3 Way Valve
Hi-Off-Low
3 Way Valve
D-Off-A&D
Vitamin A & D
Concentrate
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 73
2
E. Packaging Norms
Milk is available to consumers in pouches, plastic containers, glass bottles or
in tetra-packs. These packaged milk pouches/containers protect the milk from
outside environment and increase the shelf-life of the product.
• You must ensure that the packaging area is clean, dry and free of dust
and pests.
• Use only food grade packaging material with no strong odor and only
food grade colors.
• Always keep the packaging material covered and at least 4”above the
ground and 18” away from the walls.
• You must check the packaging material for any visible infestation, dirt
and dead insects. Do not use any infested material.
• The filling and sealing machines must be made of non-toxic, non-
corrosive material like stainless steel, aluminum etc.
• See that all the workers in packaging area follow strict hygiene
practices of hand washing and drying. They must sanitize their hands
before touching the packaging material or filling machines.
• Ensure that the packing machine are cleaned periodically.
74
• Check the transport vehicle for any dirt or pest infestation before
loading.
• Use only reefer containers or refrigerated tanks for transport of
pasteurized milk.
• You must transport the pasteurized milk at constant temperature
below 4°C. The temperature should not rise above 4°C at any point
during transportation.
• Use the vehicles for milk transport only to avoid cross-contamination.
• You must keep the surroundings of the milk plant especially, areas
around the silos, clean and dry at all times to avoid any environmental
contamination.
• For a milk processing plant, you should chose a location that is away
from industrial pollution like strong odour, fumes etc.
• You must check that the surroundings are clean with no stagnant
water or garbage dumps in the area.
• Control any excessive vegetation in the premises to avoid attracting
insects and pests. Cut the grass and shrubs short.
2) Infrastructure and Layout
• You should check that there is sufficient free space around the
machines to allow easy cleaning of floor and equipment in the
processing and packaging areas.
• Check that the floors, walls and ceilings are made of non-absorbing
and non-toxic materials like Tiles, non-porous stones, Kota stones etc.
that are easy to clean.
• It is preferable to provide the floors with slope of at least 8 degrees for
easy drainage of water into the drains to avoid water logging.
• You must screen the windows, doors, openings for ventilation with
wire mesh, strip curtains, air curtains, grills as suitable, to prevent
the entry of dust, cockroaches, rats, lizards, birds and stray animals
like dogs.
• Cover the lights and other overhead fixtures with shatter-proof
coverings like fibre, grills etc. to prevent broken glass pieces from
falling into the milk during processing and packaging.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 75
• Ensure that there is continuous supply of safe potable water for food
processing, cleaning of equipment and hand washing purposes.
3) Equipment
• Equipment and containers that are used for milk handling, storage,
preparation, processing, packaging and serving should be made of
corrosion free materials like stainless steel, aluminium, etc. which do
not impart any toxicity to the milk
• You must never leave the milk open at any stage of processing. Always
store milk in clean vessels covered with a well-fitting lid.
• You must have a cleaning-in-place (CIP) facility in a milk plant
especially in the pasteurization unit.
• Use valves to prevent back flow of milk in the pipelines and check
these valves periodically.
• Maintain the records for cleaning and maintenance of equipments.
• You should provide the floors with a slope of at least 8 degrees to avoid
water logging in the manufacturing area.
• Do not let the waste generate accumulate in the food processing or
packaging areas. You must immediately collect the wastes in covered
containers and store them away from the food handling areas.
• Dispose of the collected waste at regular intervals so that it does not
generate bad odor in the area or lead to development of microbial
growth.
• Ensure that the plastic/metal/ glass wastes are disposed of in an
environment friendly manner.
• Collect the dry and wet wastes separately and segregate the
biodegradable, non-biodegradable and recyclable wastes.
• See that there are sufficient covered dustbins in all the areas, and that
no waste is left lying in the open.
• Clean, disinfect and dry all the dustbins before next use.
• Ensure that all the drain openings are screened with metal grills or
mesh to avoid waste accumulation.
76
5) Cleaning and Maintenance
Due to multiple pipelines, valves and high risk of food contamination in milk
plant, cleaning and maintenance have to be strictly followed as per the
standard procedures including time and temperature controls for cleaning
and washing of machines.
• You must follow a regular
cleaning schedule in the milk
plant which clearly describes:
Ø
the instructions for
cleaning
Ø the time schedule for
cleaning and
Ø the person responsible for
cleaning
• Store the cleaning chemicals CIP of large milk vessels
and equipment in a separate
area.
• Keep the floors and equipment clean and dry at all times.
• Wipe the doors and windows regularly. Also clean the wire mesh, grills
and insectocuters regularly to clean any accumulated dirt.
• You must have a CIP (Cleaning In Place) system for cleaning the milk
processing equipment as bacteria may develop inside the pipelines and
valves if not cleaned properly, especially in the pasteurizing unit.
• You must follow these steps to clean the milk processing equipment to
avoid growth of bacteria due to milk residues.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 77
• You must maintain the temperature instructed to keep the equipment
germ-free.
• Do not leave the chemicals used for cleaning for longer than suggested
time to avoid corrosion of equipment.
• Maintain a record of all cleaning and maintenance activities.
Though the milk processing area is highly protected from the environment, it
is still suggested that you take some precautions to keep the insects and pests
away from the premises.
7) Personnel Hygiene
78
• You must wash hands with soap and dry them every time after using
toilets, sneezing, coughing, scratching your body parts and after
touching your mobile phones, money etc.
• Do not eat, drink or spit inside the processing area.
• Always cut your nails and keep them clean.
• Avoid wearing any jewellery like rings, bangles, watches or pins while
working in the plant. If you can’t remove these because of any personal
or religious reasons then use hand gloves to cover them.
Always use
hand gloves
Wear uniform
Train the workers and staff on how to use the machines, and how to handle
the milk and its products to ensure food safety at all stages of processing.
• You must train the workers for GMPs and GHPs to be followed in the
milk processing plant.
• Train the workers for various time and temperature controls to be
maintained during milk processing.
• You must train the workers to clean the valves, pipelines, curved ends
of the pipelines and milk containers properly with steam or vacuum
for standard time and temperature.
• You should do a skill assessment for workers periodically by way of
quiz, discussions, reviews etc.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 79
Wheat Flour 07
Content
B. Procurement Norms
C. Storage Norms
D. Process Norms
d. Fortification
E. Packaging Norms
3) Equipment Maintenance
7) Personnel Hygiene
82
A. Process Flow Diagram Wheat Flour Milling
Wheat grains
Sampling
Not approved
Incoming
Reject
Inspection
Silos
Sifting
Sooji
Maida
(Semolina)
Wheat Flour (All purpose flour)
Approved
Fortification
Approved
Silos
Warehousing, Dispatch
Primary Packaging Material Packaging
and Transportation
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 83
B. Procurement Norms
The wheat grains are received in gunny bags or in bulk in vehicles. A random
sample is taken from each vehicle and tested for quality. If found to be of
acceptable quality, the raw material is unloaded at an unloading station.
• You must inspect the incoming vehicles to ensure that wheat grains
are transported in clean vehicles.
• Sampling
Collect a sample at random from the raw material received. From this
composite sample, make a small sample of 2 kg. Divide this into two halves,
1kg for testing and the other 1 kg for retention by the quality control (QC)
department.
From the 1 Kg testing sample, use samples of 25g for testing various
parameters.
Up to 10 Each bag
• Testing
The incoming grains are tested for moisture content, foreign matter, infestation,
broken grains and damage. Label the retention sample with vehicle number, inward
gate pass number, number of bags, total weight, date of receipt, supplier details,
product name and internal QC code.
• Record keeping
a) You should maintain a record of all the incoming vehicles of raw material for
any future reference. This should include vehicle number, supplier data,
quantity of raw material received, date and time of receipt and quality
inspection results.
b) The incoming inspection records for the packaging material, fortification pre-
mix, and other chemicals also need to be maintained
84
Sample Receiving Log
C. Storage Norms
• Store the wheat grains in gunny bags and/or large silos made of non-toxic
material like stainless steel or aluminum.
• You should store the wheat grains at ambient temperature and must ensure
adequate ventilation in the storage area by means of windows and exhaust
vents.
• Store the gunny bags at least 2 feet away from the walls and 4” above the
ground on pallets to allow easy cleaning of the walls and floors.
• Clean the storage area and silos regularly and use pest control measures to
limit the entry of rats, lizards, cockroaches etc.
Use pallets for storing wheat grains You can store wheat grains in silos
in gunny bags that are clean and not corroded
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 85
D. Process Norms
The processing of wheat grains occurs in the following stages-
The wheat grains are cleaned before further processing. The stones, sticks,
metal particles, husk and other extraneous matter are removed by sieving,
magnets, aspirators, de-stoners. The grains are further washed and dried to
remove the dirt from the grain surfaces.
Conditioning is the treatment of wheat grains with water and heat to change
the structure and biochemical properties of the grains. It makes the wheat
grains soft hence making the milling and dehulling process more efficient and
quick. Moisture is increased up to 16-18% during the process.
• Check the machines for any corrosion. Do not use rusted machines.
• Use only potable water for washing of wheat grains.
86
Wetting of Wheat Grains in Closed Chambers
After cleaning and removal of husk, the wheat grains are passed through
rollers and grinders to obtain wheat flour and other products like Sooji
(Semolina) and Rawa etc. These different grades of flour are separated using
sifters based on their particle size and collected separately.
Grinding of wheat grains in chakki flour mills and roller flour mills
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 87
• Test the wheat flour for the
following parameters-
a. Moisture
b. Total Ash
d. Gluten content
• Remove the flour dust from Use vacuum cleaners for cleaning the flour dust
the floor periodically and
maintain the area clean. Use vacuum cleaners for efficient cleaning of
floors particularly around the grinding machines and also the grinding
stone where flour dust may accumulate.
4. Fortification
Day Tank
5-10 Meters
Micro dozer
Pump
88
E. Packaging Norms
Packaging process involves setting up primary packaging material, filling of
wheat flour into packages and sealing to make the finished product ready for
sale. The packaging is mainly done to protect the finished products from
getting contaminated.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 89
F. Warehousing, Dispatch And Transportation Norms
An efficient system of warehousing, dispatch and transportation needs to be
put in place to ensure that the wheat flour packages reach the consumer
safely. It must be ensured that the finished product does not get re-
contaminated during storage and distribution.
• You must keep the warehousing area clean and dry all the times to
avoid spoilage due to moisture and pests.
• Use pallets to store the packaged products at least 4 inches above the
floor and 2 feet away from the walls.
• Inside the warehouse, ensure that pest control measures like pesto-
flashes, rodent traps and glue pads are in working condition. Place
these traps in places/corners where pests are easily attracted without
disturbing the regular movement of workers and goods.
• You must check for any sign of pest activity regularly and take
immediate actions if any pest is found in and around the warehouse.
Flaking Paint
on Wall
• You must follow FIFO (First in, first out) stock rotation system during
dispatch.
• You must inspect the vehicles for cleanliness before loading the
finished product.
• You must use covered vehicles for transportation of wheat flour. If the
vehicle is open from the top or from sides, then you must cover it on all
sides with water proof material like tarpaulin sheet to protect the
finished product bags from dust, dirt and rain during transportation.
90
G. Good Hygiene Practices In Wheat Flour Mill
1. Location and Surroundings
• The flour mill should not be located in areas with high risk of floods.
• You should always check that the plant premises is free from stagnant
water, scattered garbage and scrap to maintain the plant
surroundings pest free and hygienic.
• You should have residential areas away from the manufacturing area.
• You must report any pest sighting in the surrounding areas like
insects, rats, snakes, animals, birds etc. immediately to the factory
manager and take all possible preventive steps for pest control.
• Walls and floors of the raw material storage area, production and
packaging section and the warehouse should be well maintained
without any cracks or holes to prevent rodents like rats, cockroaches
etc. from hiding and to prevent dirt from accumulating.
• Leave free space in between and around the machines especially in the
packaging section to allow easy movement and cleaning.
• It is preferable that the walls and floor should be of light color so that
any pests or dirt can be easily seen and cleaned.
• Cover the lights on the walls and ceilings with shatter-proof plastic/
fiber covering to prevent broken glass pieces from falling into the
processing area.
• Get all the windows screened with wire mesh and the drain holes
covered with metal grills to prevent pests from entering the processing
area. Clean the dirt and food dust from these wire mesh and grills
every day.
• Place air curtains or strip curtains on the doors/ entrances to prevent
entry of pests and dust/ dirt from outside.
• Warehouses should have proper ventilation and illumination. See that
there are adequate lights and windows/ exhausts for the same.
3. Equipment Maintenance
• You should periodically check that the equipment and containers are
not damaged (corroded, rusted, broken) to avoid metal particles
chipping off and entering the product stream.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 91
• Place the equipment in the processing areas with sufficient free space
such that they are easy to clean and maintain.
• Label the equipment and mark the pipelines (color coding) for easy
identification.
• You should label the vessels/ containers used for storage of wastes and
by-products (Sooji, Maida etc.) for easy identification.
• Always cover all vessels and containers containing flour with a proper
fitting cover/lid to protect the wheat flour completely from dust, dirt
and flies and other insects as well as air.
• Check the machines/equipment regularly. For e.g.
Ø
all steam supply valves and steam traps for leakage
Ø
weighing equipment for errors
Ø
grinding stones for chipping
Ø
equipment calibration
• You must lubricate the machines periodically with food grade
lubricants.
• You must cover all the openings of the drains with metal grills to avoid
garbage from entering the drains leading to blockage and also to
prevent entry of insects and rodents.
• Place waste collection bins in all the manufacturing sections of the
plant for efficient collection of waste. Number of bins should be based
on the average amount of waste generated in that particular area.
• You must dispose off the waste/scrap periodically to avoid
accumulation and
breeding of pests.
• The waste generated
shall not be disposed
into the open areas
outside the factory, on
roads or into the drains
to avoid environmental Separate and labeled containers for different
contamination. You types of wastes
must ensure that the
waste disposal is carried in eco-friendly manner at designated sites.
• Different kind of wastes like paper, food waste, plastic waste and
hazardous waste can be collected separately for easy disposal.
92
5. Cleaning And Maintenance
Ø
the instructions for cleaning,
Ø
time scheduled for cleaning, and
Ø
person responsible for cleaning
• You should store house-keeping chemicals at dedicated places to avoid
mix-up and/or mis-use by workers.
• Handle the cleaning chemicals with care and use them as per the
instructions given on the label.
• You must clean all the equipment used at the end of day’s operations.
• Clean the ceilings, walls, floors, doors, windows ,wire mesh and grills
periodically to remove any accumulated dust, dirt, spider webs etc.
• Maintain a record of all the cleaning activities in the factory.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 93
6. Pest Control System
Pests like rats, cockroaches, worms, lizards and their droppings, feathers or
wings of birds etc. are common sources of contamination in the plant and
should be prevented from entering the premises to ensure food safety.
• You must keep a check for any rats, cockroaches, spiders, lizards or
stray dogs, if seen in the premises.
• Clean the spider webs on the ceilings, walls, doors, grills etc. regularly.
• Do not allow any stray animals like dogs or cats to enter the premises.
Keep the doors of the area closed for this reason.
• You can use strip curtains, air curtains to limit the entry of insects
into the working area.
• Screen the windows and exhaust/ ventilation openings with wire mesh
to control the entry of birds from outside.
• You may use glue pads, traps, Insectocutors and insecticides/
pesticides to get rid of the pests but do not forget to cover the food
items and the equipment used for oil manufacture before you spray the
chemicals in the area.
• Use the 4D system as mentioned in the general section for pest control
management.
7. Personnel Hygiene
Hygiene of the workers is important for food safety as the workers are in
direct contact with the food. It includes the cleanliness of clothes, shoes,
hands, toilets used by the workers, as well as the health of food handlers. You
must take precautions to maintain the personal hygiene.
94
Ø
Safe potable water, soap for hand washing and hand drying facility
like hand dryers or disposable paper towels.
Ø
A facility for drying hands near the hand washing station.
Ø
A separate changing room for male and female workers to change
into clean uniforms before entering the food handling area.
Ø
A separate area/canteen for resting and eating for the workers.
• Motivate the workers to wash hands with soap and water every time
after using toilet as well as after touching foreign objects like phones,
money etc. or scratching of body parts, coughing and sneezing. Provide
them with hand sanitizers especially in the packaging area.
• You must ask the workers to trim their nails and not to wear any nail
paints as it may contaminate the wheat flour.
• You should see that the workers do not wear any Jewellery or other
accessories like bangles, watches etc. during handling of wheat at any
stage. In case of religious issues like wedding rings etc., hand-gloves
must be used. Lost items must be reported.
• You should encourage the workers to wear gloves, face masks, hair
net, uniforms at all times during the operation to avoid contamination
and teach them how to dispose these masks, gloves and hair nets. Ask
them to throw these after use in the designated bins and not in the
open.
• Do not consume alcohol, tobacco or smoke cigarette within the
processing area as it may contaminate the wheat flour.
• Do not eat food within the premises. Use the designated canteen area
or refreshment rooms for having your lunch and tea.
• Do not spit on the walls of the building.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 95
• Maintain records of these health checkups.
• In case of epidemic in your area/ city, you must get the food handlers
vaccinated.
• If suffering from any disease, the workers must inform the supervisor
and should not be allowed inside the food handling premises.
• Do not allow the workers with open cuts or wounds to handle food or
equipment.
• First aid must be available for workers in case of emergency. Maintain
a record for all first aid medicines and their consumption. Check these
records periodically.
• Provide the workers with technical training about the use of machines,
time and temperature requirements for wheat manufacture at each
stage, and also the hygiene practices that they must follow, once in
every 6-8 months.
• Evaluate the effectiveness of these training programs through periodic
assessment of workers by way of questionnaire, quiz, discussion and
reviews.
96
Standard Operating
Procedures (SOPs) 08
for testing micronutrients
Introduction
Micronutrient deficiencies of iron, zinc, lipid and water soluble vitamins are
causing serious damage to social and economic development through poorer
pregnancy outcomes, impaired learning abilities of young and reduced work
capacity and enhanced morbidity from infectious diseases. The principle
reason being inadequate intake of these micronutrient in developing
countries, refinement of ingredients like wheat, rice, milk and edible oils
resulting in loss of micronutrients & vitamins as well as poor eating habits of
modern day life style. Log growth of population in developing countries has
necessitated higher crop cultivation per acreage with use of chemical
fertilizers. This has resulted in loss of green covers that deprives of soils of
micronutrient as well as introduction of competitive inhibition of
micronutrient uptake in food chain. In addition micronutrient deficiencies
become more accentuated in vegetarian population due to limited availability
of lipid soluble vitamins and iron and zinc due to high phytate content
98
Major Problems In Micronutrient Analysis Of Food
Items
Nature of Properties of Food Items
Nature of Vehicles
These are though ideal vehicle for fortification due to universal usage, small
amounts used in daily diet preparations, easy upkeep of salt and transparent
solutions when dissolved in water making enabling estimation of
micronutrient relatively easy. Population in Indian peninsula by and large
consumes on average 8-10 gm. of salt and 34-36 grams of sugars per day per
day constituting 5-7 % of Daily Energy Intake. The fortification with minerals
though easy, the fortification with lipid soluble vitamins is not only difficult
but also results in unacceptable taste and color change.
With the exception of rice and pulses, various mass consumed food items like
wheat, maze and millets are not used up in their natural occurring forms.
Even rice and some pulses needs de-husking and polishing. People in Indian
peninsula consume 450 grams per day constituting 50 % of Daily Energy
Intake. Other staple vehicles need to be grounded in powdered forms. Thus
wheat, maize and millets like sorghum, pearl millet, and ragi need conversion
to flour for bread making. Flour production in many countries is taken as a
household activity and not amenable for fortification. This is especially true of
small towns and rural areas in developing countries of Asia and Africa. In
modern roller mills flour making process is exothermic and raises the
temperature to the tune of 60-70 °C and causes a loss of essential nutrients,
enzymes like amylases and fiber. Secondly most of these items are rich in
complex starch, phytates and proteins. In addition the color of flours also
poses a problem in spectrophotometer analysis. In summary many such
properties require extraction of analytes for final quantitative measurements.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 99
cows/buffalos/goats. India is the world's largest producer of milk, and is the
leading exporter of skimmed milk powder. People in Indian peninsula
consume 220 grams per day constituting 5 % of Daily Energy Intake. The
mass scale milk storage and distribution by dairies in both private and
cooperative sector requires careful collection, handling, and pasteurization
and cold chain distribution network. Because of rancidity problem excess milk
is converted to other products including cheese and milk powder with greater
shelf life. Since milk contain proteins, fats, lactose, and various vitamins and
minerals. The estimation of micronutrients in milk requires extraction with
organic solvents to precipitate proteins and extract lipid soluble vitamins.
Edible Oils:
People in Indian peninsula largely use vegetable oils from mustard, peanut,
safflower, soybean, sunflower and recently also started using palm oil as
major cooking medium. These oils are the source of fat soluble vitamins like
A, D & E and provide energy, and essential fatty acids that are required for
proper growth and development. Though the production is high throughout
the world, and consumption is increasing, especially among the lower
socioeconomic groups. People in Indian peninsula consume 15-20 grams per
day constituting 5-7 % of Daily Energy Intake. Mass scale producers though
less in numbers produce refined oils but majority in rural areas consume
locally produced oil that are rich in odor and color. Not only is the color of oils
a major problem in measurement of vitamins the extraction and purification
of fortified vitamins is a major problem in their estimation.
Stability
Daily diet includes food items made of rice or various flours from wheat,
maze, soya as well as edible oils, salt and milk products. Food items are
complex materials due to ingredients being mixed in unknown proportions,
their blending and processes use like heat treatment, frying cooking etc.
However micronutrient analysis of ingredient though difficult can be
100
performed following a general principle of extraction, separation techniques
and final detection and quantitation by physio-chemical techniques
Food items – (1) Wheat, Maze, Soya flours, (2) Milk, (3) edible oils
05 Final Quantitation
6.1 Colorimetry
6.2 Spectrophotometry
6.3 Turbidimetry
6.4 fluorescence
6.5 Electrochemical
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 101
Operating Procedures and Principles of Estimations:
A quality assurance system must be set up to ensure that the manufactured
food is safe, unadulterated, properly labeled, and meets all the company’s
specifications and government regulations (Table 1). Food samples must be
representative and selected at random, with an adequate and reproducible
sampling procedure. Personnel must be trained in the assay method(s), that
should have been previously identified or set-up. Equipment required must be
available on-site in working condition.
102
Lastly, in some respect microbial assays are better than chemical assays
because any suitable change in vitamin molecule may not be detected by
chemical method will be revealed by change in microbial activity. The
microbial assays of the vitamins are based on comparison of stimulation of
growth of a specific bacterium by unknown concentration of vitamins added to
foods with that produced by known concentration of standard preparation of
vitamin having known activity. Since end product measurement can either be
carried out either by turbidimetry or color measurement these assays are
relatively cheaper. Their adaptability to automation in terms of ELISA
development further increase their use and cost economics. Microbial assays
of the vitamins, and of other nutrients such as amino acids, are still a
research necessity, despite the encroachment of physico-chemical techniques
for standardization. Although their role in standardization is shrinking, the
need of industry for quantitative bioassays assay, with a measurable
precision has produced some useful designs and calculations that the research
worker could adopt with profit.
Mineral Analysis:
Most prominent fortificants e.g. Iodine and iron can be qualitatively analyzed
or detected with simple color development ability with certain chemical
reagents (spot testing), their quantitative analysis requires either simple
titration (for salt iodine) or colorimetric analysis of digested flours. Some
micronutrients can be detected using relatively simple colorimetric methods.
Many studies compared the dry ashing and wet digestion methods of
processing food samples for elemental analysis. The concentrations of trace
elements (manganese, iron, copper and zinc) and heavy metals (chromium,
cadmium, lead and nickel) were determined in varieties of samples classified
as fruits, leafy and fruity vegetables, tubers, legumes and cereals using
atomic absorption spectrophotometer according to standard methods. The
accuracy of the procedures was confirmed by spiking some samples and
evaluating their recoveries. The metal levels evaluated were relatively higher
in the dry-ashed samples than the wet-digested samples. However, the
results showed non-significant differences in most data obtained after
processing with the two methods. The dry ashing method is recommended for
digestion of food items in these categories because: it involves lesser amount
of chemical reagents and related hazards; it requires simple equipment and
achieved better recovery.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 103
Iodine Assays
Qualitative method-Spot test:
Quantitative Methods:
Titration procedures also are specific to the form of iodine in salt. In samples
fortified with iodate, addition of an acidic solution liberates free iodine from
salt iodate. Free iodine is then titrated with thiosulfate and the amount of
thiosulfate used is proportional to the amount of iodine in salt. In salt
fortified with iodide, bromine oxidizes iodide ions to free iodine, which is
titrated with thiosulfate solution. It is a fairly simple and rapid technique
compared with the liquid chromatography method. However, it requires
personnel with good laboratory skills.
Equation:
Iron Assays
Qualitative method:
104
Figure 1 Field wheat flour iron detection kit
MDL has developed a Test Kit to determine the iron content of flours – even
in the absence of a fully equipped laboratory. The MDL Test Kit is a semi-
quantitative screening tool that allows to assess the concentration of Iron in
any form in flour. This cost-effective micro-laboratory – about the size of your
palm – is disposable, easy to use and robust. The kit can be easily use by
fortified flour manufacturers, anaganwadi workers and mid-day meal
managers under laboratory and field conditions. It lowers the cost of quality
control down to an average cost of less than a dollar.
Quantitative Methods:
Dry ashing:
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 105
Wet ashing:
Iron detection: Once the iron has been extracted, it is detected using
colorimetric or atomic absorption spectrophotometric (AAS) methods.
106
The general extraction procedure for fat soluble and water soluble vitamins in flour
samples is outlined in following paragraphs. These methods need suitable
modifications for items like sugars, milk, and edible oils. However these methods
need validation for each individual vitamins.
Wheat or maze flours and their preparations like breads etc. consists of many
components that cause chromatographic interferences with vitamins. For this reason
the sample treatment proposed consists of SPE with Sep-Pak C18 (500 mg) cartridges
that enable separation of water-soluble vitamins and remove most of the interfering
components. 20 ml of deionised wateris added into one part of flour/bread (5 g). The
mixture is homogenized using a homogenizer at medium speed for 1 min. The
homogenized samples are centrifuged for 10 min at 14 X 103g. The SPE method of
Cho et al. [7] is used for the extraction of water-soluble vitamins. The stationary
phase is flushed with 10 mL methanol and 10 mL water adjusted to pH 4.2 to
activate the stationary phase. Homogenized and centrifuged supernatant of
flour/bread (10 ml) is the loaded. Acidified water is prepared by adding a 0.005 M HCl
solution drop by drop with stirring until the pH reached a predetermined value. The
sample is eluted with 5 mL water (pH 4.2) then 10 mL methanol at a flow rate of 1
mL min- 1. The eluent is collected in a bottle and evaporated to dryness and dissolved
in appropriate solvent for injection
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 107
Vitamin A Assays:
Vitamin A is one of the most unstable micronutrients. Industrially produced
vitamin A, like retinyl palmitate, is more stable than naturally occurring
vitamin A, although it remains sensitive to air, light, moisture, heat, and acid
conditions. Vitamin A levels have been determined using colorimetric and
spectrophotometric methods for a long time. Currently, HPLC is the method
of choice. The use of HPLC is preferred when samples have a significant
amount of interfering substances such as other vitamins, minerals, proteins,
and carbohydrates.
Semi-Quantitative Method:
Colorimetric Method:
108
Figure 2 depicting milk vitamin A color development in proportion to the
concentration of vitamin A
C. Though the color fades within 5-6 minutes but it is good enough to allow timely
reading in a single wavelength colorimeter
The successful use of chromogenic based methodology for edible oil vitamin A can be
seen in Fig 3
Figure 3
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 109
Soya oil OD at 490 Sun flower oil OD at 490
Quantitative method:
Spectrophotometric method:
The sample is irradiated with UV light and its absorbance is measured. The
absorbance is proportional to the vitamin A content in the sample. The
spectrophotometric method can be used to monitor vitamin A levels in fortified
products at the production level
HPLC method:
In this method, retinol is separated from other substances, which absorb
radiant energy at equal or similar wavelengths to retinol, using hexane.
Retinol is then detected using spectrophotometric or fluorometric techniques.
110
A typical HPLC chromatograph of retinol analysis is presented in Fig 4. The
HPLC method is very reliable mainly because of its ability to effect rapid
separation and the high resolution achieved. High costs of equipment, and
time required, do not permit several measurements per shift. Highly trained
personnel are also required.
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 111
Microbiological assays are preferred over colorimetric methods for foods
containing high levels of Maillard browning products (for example, cocoa
products), in order to minimize color interference. Microbiological assays for
quantifying pyridoxine (vitamin B6) and its isomers, pyridoxal and
pyridoxamine, rely on the growth response of Saccharomyces uvarum.
Microbiological assays are also used for quantitative determination of folic
acid (B9), pantothenic acid, and vitamin B12 in foods. The test organisms
used in folate assays are Streptococcus faecalis or Lactobacillus casei.
Saccharomyces carlbergensisand Lactobacillus plantarum are common test
organisms used in determining pantothenic acid because they do not grow in
the absence of pantothenic acid. Similarly, vitamin B12 can be determined
using microbiological assays with the test organism, Lactobacillus
leichmannii. High pressure liquid chromatography (HPLC) methods to
determine most B-complex vitamins have been considered and evaluated, but
have not yet been validated as official methods by the Association of Official
Analytical Chemists (AOAC). There is ongoing interest in developing and
validating these methods. Techniques also exist for simultaneous
determination of all water-soluble vitamins by HPLC using UV/visible
spectrophotometric detection.
Vitamin C assays
Vitamin C can be quantitatively analyzed by either titrimetric or fluorometric
methods. The titrimetric method involves the measurement of decolorization
of 2,6-dichloroindophenol dye by ascorbic acid. This method is not suitable for
highly colored products (for example, colored fruit juices) because of the
difficulty of determining the endpoint during titration. The fluorometric
method involves oxidation of ascorbic acid to dehydroascorbic acid, which
reacts with phenylenediamine to produce a fluorescent compound whose
intensity is proportional to the vitamin C concentration.
Vitamin D assays:
Vitamin D is quantitatively determined using liquid chromatography. After
saponification and extraction of the sample, purification is achieved by
sequentially using alumina and silica columns.
Vitamin E assays:
Vitamin E levels can be determined spectrophotometrically, although the
HPLC method with fluorescence detection is preferred, as it permits the
measurement of different forms of vitamin E; thus, total vitamin E activity.
However, it is a sophisticated technique and requires trained personnel to
execute the analysis.
112
Microbial Assays for Water-Soluble Vitamins
Vitamin B-complex Assays:
Thiamin (Vitamin B1) is extracted from the sample and the extract is
diluted. The diluted extract and the vitamin B1-assay-medium are pipetted
into the wells of a microtiter plate which is coated with Lactobacillus
fermentum. The growth of Lactobacillus fermentum is dependent on the
supply of vitamin B1. Following the addition of vitamin B1 as a standard or
as a compound of the sample, the bacteria grows until the vitamin is
consumed. The incubation is done in the dark at 37 °C (98.6 °F) for 44-48 h.
The intensity of metabolism or growth in relation to the extracted vitamin B1
is measured as turbidity and compared to a standard curve. The
measurement is done using a microtiter plate spectrophotometer at 610 – 630
nm (alternatively at 540 – 550 nm).
Riboflavin (Vitamin B2) is extracted from the sample and the extract is
diluted. The diluted extract and the vitamin B2 assay-medium are pipetted
into the wells of a microtiter plate which is coated with Lactobacillus
rhamnosus. The growth of Lactobacillus rhamnosus is dependent on the
supply of vitamin B2. Following the addition of vitamin B2 as a standard or
as a compound of the sample, the bacteria grow until the vitamin is
consumed. The incubation is done in the dark at 37 °C (98.6 °F) for 44 – 48 h.
The intensity of metabolism or growth in relation to the extracted vitamin B2
is measured as turbidity and compared to a standard curve. The
measurement is done using a microtiter plate spectrophotometer at 610 – 630
nm (alternatively at 540 – 550 nm).
Niacin (Vitamin B3) is extracted from the sample and the extract is diluted.
The niacin assay – medium and the diluted extract are pipetted into the wells
of a microtiter plate which is coated with Lactobacillus plantarum. The
growth of Lactobacillus plantarum is dependent on the supply of niacin.
Following the addition of niacin as a standard or as a compound of the
sample, the bacteria grow until the vitamin is consumed. The incubation is
done in the dark at 37 °C (98.6 °F) for 44 – 48 h. The intensity of metabolism
or growth of Lactobacillus plantarum in relation to the extracted niacin is
measured as turbidity and compared to a standard curve. The measurement
is done using an microtiter plate spectrophotometer at 610 – 630 nm
(alternatively at 540 – 550 nm)
Pantothenic acid (Vitamin B5) is extracted from the sample and the
extract is diluted. The diluted extract and the pantothenic acid assay-medium
are pipetted into the wells of a microtiter plate which is coated with
Lactobacillus plantarum. The growth of Lactobacillus plantarum is dependent
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 113
on the supply of pantothenic acid. Following the addition of pantothenic acid
as a standard or as a compound of the sample, the bacteria grow until the
vitamin is consumed. The incubation is done in the dark at 37 °C (98.6 °F) for
20 – 24 h. The intensity of metabolism or growth in relation to the extracted
pantothenic acid is measured as turbidity and compared to a standard curve.
The measurement is done using a microtiter plate spectrophotometer at 610 –
630 nm (alternatively at 540 – 550 nm).
Pyridoxin (Vitamin B6) is extracted from the sample and the extract is
diluted. The diluted extract and the vitamin B6 assay-medium are pipetted
into the wells of a microtiter plate which is coated with Saccharomyces
cerevisiae. The growth of Saccharomyces cerevisiae is dependent on the
supply of vitamin B6. Following the addition of vitamin B6 as a standard or
as a compound of the sample, the bacteria grow until the vitamin is
consumed. The incubation is done in the dark at 30 °C (86 °F) for 44 – 48 h.
The intensity of metabolism or growth in relation to the extracted vitamin B6
is measured as turbidity and compared to a standard curve. The
measurement is done using a microtiter plate spectrophotometer at 610 – 630
nm (alternatively at 540 – 550 nm).
Biotin (Vitamin B7) is extracted from the sample and the extract is diluted.
The diluted extract and the biotin assay-medium are pipetted into the wells of
a microtiter plate which is coated with Lactobacillus plantarum. The growth
of Lactobacillus plantarum is dependent on the supply of biotin. Following the
addition of biotin as a standard or as a compound of the sample, the bacteria
grow until the vitamin is consumed. The incubation is done in the dark at 37
°C (98.6 °F) for 44 – 48 h. The intensity of metabolism or growth in relation to
the extracted biotin is measured as turbidity and compared to a standard
curve. The measurement is done using anmicrotiter plate spectrophotometer
at 610 – 630 nm (alternatively at 540 – 550 nm).
Folic acid (Vitamin B9) is extracted from the sample and the extract is
diluted. The diluted extract and the folic acid assay-medium are pipetted into
the wells of a microtiter plate which is coated with Lactobacillus rhamnosus.
The growth of Lactobacillus rhamnosus is dependent on the supply of folic
acid. Following the addition of folic acid as a standard or as a compound of the
sample, the bacteria grow until the vitamin is consumed. The incubation is
done in the dark at 37 °C (98.6 °F) for 44 – 48 h. The intensity of metabolism
or growth in relation to the extracted folic acid is measured as turbidity and
compared to a standard curve. The measurement is done using amicrotiter
plate spectrophotometer at 610 – 630 nm (alternatively at 540 – 550 nm).
114
delbrueckii subsp. lactis (leichmannii). The growth of Lactobacillus
delbrueckii is dependent on the supply of vitamin B12. Following the addition
of vitamin B12 as a standard or as a compound of the sample, the bacteria
grow until the vitamin is consumed. The incubation is done in the dark at 37
°C (98.6 °F) for 44 – 48 h. The intensity of metabolism or growth in relation to
the extracted vitamin B12 is measured as turbidity and compared to a
standard curve. The measurement is done using a microtiter plate
spectrophotometer at 610 – 630 nm (alternatively at 540 – 550 nm).
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 115
Levels of Fortification In Gain Supported Projects
A. Wheat Flour
The WHO guidelines for food fortification are the guiding principles for the
project, based on the estimated consumption level of wheat flour between
150g and 250g.
ü
Iron (as NaFeEDTA): 5ppm
ü
Iron (as Electrolytic iron): 50ppm
ü
Folic Acid (as folic acid): 1.3ppm
ü
Vitamin B12 (as Cyanocobalamin): 0.01ppm
ü
Vitamin A (as Vitamin A palmitate): 1.5 ppm
ü
Iron (as Ferrous Sulfate): 30ppm
ü
Folic Acid (as folic acid): 1.3ppm
ü
Vitamin B12 (as Cyanocobalamin): 0.01ppm
ü
Vitamin A (as RetinylPalmitate): 25,000 IU per kg of oil
ü
Vitamin D2: 2,000 IU per kg of oil
ü
Vitamin A (as Retinyl Acetate, 2000 IU per litre of milk
water miscible):
ü
VitaminD2: 400 IU per litre of milk
ü
Iron (electrolytic iron): 2600mg / kg of dal
ü
FolicAcid: 30mg/ kg of dal
116
List of NABL Accredited
09
Laboratories
FSSAI Notified NABL Accredited Food Testing Laboratories [S.O. 917
(E) dated 01.04.2015] for the Northern Region for the purposes of
carrying out Analysis of Samples Taken under Section 47 of the Food
Safety and Standard Act, 2006
(Note: following list covers Northern (Delhi) Region only. Visit fsssai.gov.in
for updated list of notified laboratories in other parts of the country.)
A. NORTHERN REGION
Delhi
118
Sr. Name and Contact detail of Registration Chemical Biological Mechanical
No. the Laboratory Number Scope of Scope of Scope of
accreditatio
accreditation accreditation
n (valid till)
(valid till) (valid till)
A. NORTHERN REGION
Delhi
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 119
Sr. Name and Contact detail of Registration Chemical Biological Mechanical
No. the Laboratory Number Scope of Scope of Scope of
accreditatio
accreditation accreditation
n (valid till)
(valid till) (valid till)
A. NORTHERN REGION
Delhi
120
List of Gain Approved Premix Suppliers
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 121
4. Piramal Enterprises Limited
247 Business Park,
A – Wing, 6th Floor
LBS Marg, Vikhroli (West)
Mumbai 400083.
Maharashtra, India
+91 22-309566666
5. P D Navkar
Head Office
109 & 110, 4th Phase
KIADB Industrial Area
Bommasandra - Jigani Link Road
Bandenallasandra, AnekalTaluk
Bangalore 560 015, Karnataka, India
Ph: +91 80 22157444
Email [email protected]
6. Glanbia Nutritionals
Customer Service Office
Asia Pacific — Singapore
SingaporePte Ltd.
700 Beach Rd #03-01
Singapore 199598
TEL: +65 6222 0118
FAX: +65 6222 0117
Email: [email protected]
122
8. Hexagon Nutrition Corporate Headquarters (Mumbai):
404/A, Global Chambers, Off. Link Road
Andheri (West), Mumbai 400 053, India
+91 22 2674 4740
a. Hexagon Nutrition (Chennai):
Plot No. B11, Phase 1 | MEPZ-SEZ
Tambaram, Chennai 600 045, India
+91 44 2262 5252
b. Hexagon Nutrition (Nashik):
Plot No 92A, Unandanagar
Lakhmapur Phata, Lakhmapur Village
Dindori Taluka, Nashik District 422202, India
+91 88066 61627
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 123
References 10
• Food Safety Standard and Authority of India (FSSAI)
• USFDA PMO-2011
Ø
AACC. 1994. Approved methods of the American Association of Cereal
Chemists. Eighth edition. American Association of Cereal Chemists,
Inc. Minnesota, USA.
Ø
AOAC. 1993. Methods of analysis for nutrition labeling. Edited by
D.M. Sullivan and D.E. Carpenter. Association of Official Analytical
Chemists International, Arlington, Virginia, USA.
Ø
Dustin, J.P. and Ecoffey, J.P. 1978. A field test for detecting iodine-
enriched salt. Bulletin of the World Health Organization. 56(4):657-
658.
Ø
Manual of Methods for Determining Micronutrients in Fortified Foods,
A2Z US Aid project, 2010
126
• Web Links:-
• http://dairyextension.foodscience.cornell.edu/resources/
food-safety/good-manufacturing-procedures/cleaning-and-
sanitizing-procedures
• http://www.fao.org/docrep/w9474t/w9474t03.htm
• http://documents.wfp.org/stellent/groups/public/documents/
manual_guide_proced/wfp251175.pdf
• http://www.fssai.gov.in/
• Articles:-
• http://epaperbeta.timesofindia.com/Article.aspx?eid=31808&
articlexml=Countrywide-FSSAI-alert-on-milk-water-edible-oil-
23062015009029
GMP and GHP Guideline Manual for Processing and Fortification of Edible Oil, Wheat Flour and Milk 127
FSSAI Regulation
11
on labeling
130
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132
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136
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138
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140
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142
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144
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146
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148
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150
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152
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154
Gazette Notification on
12
fortified food products
156
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158
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160
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164
Notes
Notes
The Confederation of Indian Industry (CII) works to create and sustain an environment conducive to the development
of India, partnering industry, Government, and civil society, through advisory and consultative processes.
CII is a non-government, not-for-profit, industry-led and industry-managed organization, playing a proactive role in
India´s development process. Founded in 1895, India's premier business association has over 7900 members, from the
private as well as public sectors, including SMEs and MNCs, and an indirect membership of over 200,000 enterprises
from around 240 national and regional sectoral industry bodies.
CII charts change by working closely with Government on policy issues, interfacing with thought leaders, and
enhancing efficiency, competitiveness and business opportunities for industry through a range of specialized services
and strategic global linkages. It also provides a platform for consensus-building and networking on key issues.
Extending its agenda beyond business, CII assists industry to identify and execute corporate citizenship programmes.
Partnerships with civil society organizations carry forward corporate initiatives for integrated and inclusive
development across diverse domains including affirmative action, healthcare, education, livelihood, diversity
management, skill development, empowerment of women, and water, to name a few.
In its 120th year of service to the nation, the CII theme of “Build India- Invest in Development, A Shared
Responsibility”, reiterates Industry´s role and responsibility as a partner in national development. The focus is on four
key enablers: Facilitating Growth and Competitiveness, Promoting Infrastructure Investments, Developing Human
Capital, and Encouraging Social Development.
With 66 offices, including 9 Centres of Excellence, in India, and 8 overseas offices in Australia, Bahrain, China, Egypt,
France, Singapore, UK, and USA, as well as institutional partnerships with 312 counterpart organizations in 106
countries, CII serves as a reference point for Indian industry and the international business community.
Global Alliance for Improved Nutrition is an alliance driven by the vision of a world without malnutrition. Created in
2002 at a Special Session of the UN General Assembly on Children, GAIN supports public-private partnerships to
increase access to the missing nutrients in diets necessary for people, communities and economies to be stronger and
healthier. In less than a decade, GAIN has been able to scale its operations by working in partnership with
governments and international agencies, and through projects in more than 30 countries, reaching an estimated 811
million people with nutritionally enhanced food products. About half of the beneficiaries are women and children.
GAIN's goal is to reach 1 billion people by 2015 with nutritious foods that have sustainable nutritional impact.
GAIN is a Swiss foundation headquartered in Geneva with a special international status granted by the Swiss
government. Its worldwide presence includes country offices in Abuja, Accra, Addis Ababa, Dhaka, Kabul, Jakarta,
Nairobi, and New Delhi. It also has representative offices in Amsterdam, London, Singapore and Washington D.C.
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