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MF-2505

Current Good
Manufacturing
Practices (cGMPs)
in Manufacturing,
Packing, or Holding
Human Foods
Fadi Aramouni, Ph.D., Extension Specialist, Food Systems

Tom B. Lindquist, M.S., Extension Associate,


Kansas Value-Added Foods Lab Manager

T
he Current Good Manufacturing Practice Disease control and cleanliness
Regulations (Code of Federal Regulations, Personal cleanliness
Part 110, sometimes referred to as GMPs), • Daily bathing is required before work.
were implemented by the Food and Drug • Hair must be washed at least once a week.
Administration (FDA), to establish manufacturing • Nails should be kept clean and properly trimmed.
standards for food products. These regulations were • Jewelry is not permitted on the production floor.
mandated to ensure the safety and wholesomeness of • Disposable gloves must be worn if bandages or
the processed food supply. All areas of food processing cuts are present on hands.
are covered in this publication to include personnel, • Communicable illnesses must be reported;
buildings and facilities, equipment, and production and
personnel affected or suffering from open lesions
process controls. Each of these areas will be discussed.
or infected wounds should not be allowed to work
with edible food products.
Personnel
The food plant personnel are vital to a company’s Uniforms and underclothing
success. It is management’s responsibility to educate • Uniforms/frocks must be kept clean and neat.
personnel on the fundamental principles of food plant • All frocks and equipment will be removed before
sanitation, and the importance of personal hygiene. using restrooms.
Regulations state that necessary measures be taken to • Frocks will not be worn outside of the plant.
ensure disease control, cleanliness; and proper • Frocks worn in raw product area must be
education, training, and supervision to enforce removed; and clean frocks worn in cooked product
compliance. The following are strategies to help in areas.
personnel education. • Pockets are not permitted above the waistline.
• Protective shoes and eyewear should be worn if
appropriate.
• Sweaters (or like clothing) should be avoided or
covered by a uniform.

Kansas State University Agricultural Experiment Station and Cooperative Extension Service
2

• Uniforms should be changed if soiled. • Urinals and toilets must be flushed after each use.
• Pants must be tucked into boots. • Maintenance tools or parts are not permitted on
• Boots need to be cleaned before entering food contact surfaces.
processing area. • Eating or drinking must be done in specified areas,
separate from food processing area.
Hair restraints • Lockers should be kept clean and orderly.
• Hair must be covered; hair bonnets are preferred.
• Hair bonnets should be new and unused. Each Education and training
Employees that lack the necessary training have
time a bonnet is removed it should be discarded.
proven to be detrimental to a quality assurance
• Males must be clean-shaven or facial snoods are
program. Human error is frequently the cause of
necessary. Moustaches are permitted if trimmed product failure and noncompliance. Every position has
and above the corners of the mouth. a unique set of manual, technical, and administrative
• Sideburns must be covered above ear lobes. skills necessary to complete the job effectively. The
level of competency necessary for a task depends on the
Handwashing position.
• Hands must be washed following proper For personnel handling food, it is especially
handwashing procedure (see handwashing important to train in the area of sanitation. This training
procedure at the end of this section). should emphasize the importance of personal hygiene,
• Hands must be washed after: proper food handling procedures, proper sanitation,
– Coughing or sneezing record keeping, testing, and process procedures.
– Using the restroom Training should be done when the employee is hired
– Smoking and continued throughout the length of their
– Breaks employment. It is necessary to take the education level
– Handling soiled containers, waste materials, and prior training of the employee into consideration.
or animal products Present material to the employee at the appropriate
– Using the telephone level and in a variety of methods to include; visual
• Handwashing must be made convenient. signs, videos, lectures by speakers, demonstrations,
role-playing and hands-on-training. Forms of training
Sinks with hot water are necessary for proper
could include:
washing habits.
• All personnel equipment should be cleaned at the • Demonstrations of bacterial transmission. A
end of each shift, or more often if necessary. visual demonstration using a product called Glow Germ
• Wall-mounted dispensers of anti-bacterial soap is a very effective tool in teaching the necessity of
and sanitizing solution should be placed beside handwashing and personal hygiene. This product uses
sinks, and rolls of clean disposable towels made invisible oil and ultraviolet lights to mimic the
available. transmission of microbes through personal contact and
• To minimize contact with germs on faucet handles handwashing. Call K-State Research and Extension,
by dirty hands, workers should be trained to shut Value-Added Foods Lab at: (785)532-1667, for more
off the water with the towel after drying their information.
hands.
• If there is a door in the handwashing area, • Petri plate testing. A demonstration tool for
employees should open the door with the towel, teaching the importance of proper personal hygiene and
then dispose of the towel as they exit the room. plant sanitation involving the use of petri plates. Plates
are inoculated with various bacterial sources, such as
Conduct dirty fingers, hair, coins, saliva, and samples collected
• Running, horseplay, and riding on equipment are from floors and counters. Incubate the petri dishes and
discover what grows.
not allowed.
• Spitting, smoking and chewing tobacco are not
allowed.
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• Signs. Very useful if placed where readily visible. Plant Construction and Design
Signs provide the proper procedures for certain tasks The plant needs to be easily cleaned and sanitized.
and can be easily referenced using visual signs and The placement of equipment has a direct impact on ease
reminders. It is beneficial if signs and training materials of cleaning and accessibility. By providing sufficient
are presented in a multilingual format if English is a room for proper cleaning and sanitizing, the process
second language for some personnel. There are many will be much easier. The floors, walls, and ceilings
sign ideas available for free through the USDA Center should be easily cleaned and kept in a sanitary
for Food Safety and Applied Nutrition. condition. Floors should be slightly sloped to allow for
There are many imaginative and fun ways to stress proper drainage and avoid water accumulation.
the importance of good manufacturing practices. Fixtures, ducts, and pipes should be suspended away
Incentive programs, such as knowledge contests or from working areas and aisles, and working areas kept
drawings are positive, effective ways to get employees unobstructed. Ventilation and lights should be
directly involved in good manufacturing practices. adequate; and lights enclosed in safety fixtures to avoid
contamination due to breakage. Separating the food
processing area from the rest of the facility is a
Supervision necessity to reduce the potential for contamination. To
Proper supervision is necessary to ensure that minimize pests, door and windowsills should be tight.
personnel are using GMP’s. Management must make Windows should be protected with screens, as well as
regular, routine inspections of processing areas as well other openings that would allow unwanted pests. Drains
as personnel areas, such as restrooms and locker rooms need traps and proper covers or grills.
to check for violations. A sample checklist is provided
at the end of this section and can be modified for
appropriateness. It is also the responsibility of Sanitation
management to inform employees about good The most important aspect in sanitation is the
manufacturing practices and make sure that the commitment to producing safe, wholesome products in
regulations are understood. A copy of the Good a clean plant environment. This commitment must
Manufacturing Practices found in the Code of Federal come from management and be communicated to all
Regulations, Part 110, should be given to each employees. It is important to assign at least one
employee. The employee should be asked to read the employee to be responsible for sanitation practices in
regulations and sign a statement indicating that they the manufacturing facility. Support of this employee’s
have read them and will comply. needs is essential, and management should require daily
reports from this employee. This employee should have
Buildings and Facilities training in the areas of microbiology, chemistry, and
Plant and Plant Grounds entomology, whether it is in the form of a degree or
The regulations for maintenance of buildings and short course on these subjects. Once a sanitation
facilities refer to the structures under the company’s program is established, it is important that
control. The immediate vicinity of a facility must be improvements be made as new developments
kept clean from trash and refuse. The roads and parking continually arise. The sanitation program's top priority
lots associated with the facility should be paved to should be to communicate to all employees the
avoid unintentional contamination. Grass or weeds necessity and importance of proper cleaning and
around the facility should be mowed or kept short to sanitation practices. The Code of Federal Regulations,
eliminate breeding or harboring of pests. This is Part 110, Subpart B, gives specific guidelines
especially important as rodents, birds, and insects carry concerning sanitary operations, facilities, and controls.
numerous types of disease that can be transmitted to or These should be read and fully understood by
hazardous to humans. Adequate drainage of facility management and sanitation personnel.
grounds is essential to eliminate seepage, tracking of
dirt, and pest breeding grounds. If problems are present
in areas not under the company’s control, appropriate
measures need be taken to ensure that those areas will
not present any type of contamination (i.e.
extermination of pests).
4

Equipment Production and Process


While each processing facility has different pieces of
equipment that is specific for the food it is producing,
Controls
Each processing facility will have a unique process
certain factors are universal when designing and
specifically designed for the product that it produces.
installing equipment. Since this equipment must
The CFR guidelines should be used to reference
produce sanitary food products, it is important to plan
specific needs but some general guidelines are listed
and operate following specific guidelines. General
below.
guidelines are listed below and further reference should
• All operations in receiving, transporting,
be made to the Code of Federal Regulations, Part 110,
Subpart C. packaging, preparing, processing, and storing of
food must follow sanitary principles.
General Guidelines • Raw materials must be inspected and separated
• Food contact surfaces should be inert under from processed products.
conditions of use, smooth and non-porous. • Raw material containers need to be inspected.
Stainless steel is preferred, wood is not permitted. • Ice, if used, must be sanitary if used for food
All surface seams should be smooth, continuous, production.
and flush with surface. • Food processing equipment should be inspected
• Equipment contact surfaces should be easily and cleaned on a regular basis.
cleaned and sanitized by using access doors, • Processing factors such as time, temperature,
removable covers or disassembly. humidity, pressure, and other relevant variables
• Equipment assembly parts such as bolts, nuts, must be properly controlled and documented.
washers, and gaskets should be kept away from • Testing procedures must be in place to check
food during equipment operation. Moving parts finished product for quality and safety.
should have sealed or self-lubricating bearings. • Packaging materials must be approved and
• Installation of equipment should allow for 3 feet provide appropriate protection.
of clearance around, and 6 inches off of the floor • Finished products must be coded to provide
for the working area and proper cleaning. information such as place and date of production.
Equipment should be installed considering • Production records need to be correctly
convenience, serviceability, and maintenance. maintained and retained for an appropriate
• Clean in place systems are preferred over cleaning amount of time specified in the CFR.
out-of-place systems. • Products must be warehoused and shipped under
• Motors, pulleys and drums should be fully sanitary conditions and away from harmful
enclosed and sealed, and not mounted directly substances.
above food contact surfaces. There are special regulations for low-acid foods (Part
• Conveyors and conveyor parts need to be fully 113), acidified foods (Part 114), bottled water (Part
accessible for easy cleaning. 129), and infant formula (Part 107). The Code of
• Valves for water and steam should not allow for Federal Regulations Web site can be accessed at: http//
leakage; and valves for food should be easily www.access.gpo.gov/nara/cfr/waisidx_01/
disassembled for cleaning and inspection. 21cfr2_01.html
• Pipes, irons, and beams should be installed
following very specific guidelines. These are By following these guidelines and those mandated in
referenced in the CFR, Part 110, Subpart C. the Code of Federal Regulations, a company can
manufacture a product that meets the needs of their
• Kettles or cookers require lids and a self-draining
consumers and operate the processing facility in a safe
design.
and efficient way. By doing this, employees will be
more productive and have fewer accidents. Consumers
will be less likely to complain about products, in turn
benefiting both the consumer and producer.
5

PERSONNEL INSPECTION CHECKLIST

YES NO
Are workers with communicable illnesses prohibited from working with food
products?

Are uniforms/frocks clean and neat?

Do workers wash their hands after using restroom?

Do workers wash their hands before returning to work and after eating/breaks?

Are workers informed of proper handwashing procedures?

Do workers remove jewelry or personal effects while working?

Do workers pay attention to personal hygiene?

Do policies prohibit eating, drinking or tobacco usage in the processing area?

Are routine training programs held?

FACILITIES/EQUIPMENT/UTENSILS CHECKLIST
YES NO

Are grounds clean, well drained and free of waste


(especially at corners and cracks where it's hard to reach)?

Are employees using their lockers properly?

Are lockers and bathrooms cleaned regularly?

Are measures taken to prevent water condensation on the ceiling or anywhere


in the plant ?

Is paint or lamination prevented from peeling off handles or other surfaces,


causing contamination?

Are all electric wires safe and away from water and sinks?

Are sanitizers and chemicals separated from products and raw materials?

Are temperature and pH instruments calibrated regularly?


6

Hand Washing Techniques

1. Wet hands with warm water. 2. Lather to your elbows.


Lather with soap. Scrub hands for 20 seconds

3. Rinse hands and elbows thoroughly. 4. Dry hands with a single use towel.

5. Use towel to turn off faucet. 6. Use towel to open the door.

Issued in furtherance of the Cooperative Extension work, Acts of May 8


and June 30, 1914, in cooperation with the U.S. Department of Agriculture,
Kenneth R. Bolen, Director of Cooperative Extension, University of
Used with permission by Julie A. Albrecht, Nebraska, Institute and Natural Resources.

Extension Food Specialist and Susan S. Cooperative Extension provides information and educational programs to
Sumner, Extension Food Microbiologist. all people without regard to race, color, national origina, sex or handicap.
Pictures Courtesy of Dianne Peters This poster is supported by the Extension Service U.S. Department of
Agriculture, under Special Project Number 92-EFSQ-1-4051
7

Técnicas de Lavado de Manos

1. Mójese las manos con aqua tibia y enjabónese 2. Enjabónese y forme espuma hasta los codos.
las hasta formar espuma. Refriéguese las manos durante 20 segundos.

3. Enjuáguese bien las manos y los codos. 4. Séquese las manos con una toalla desechable.

5. Úse la misma toalla para cerrar la llave. 6. Úse esa misma toalla para abrir la puerta.

Issued in furtherance of the Cooperative Extension work, Acts of


May 8 and June 30, 1914, in cooperation with the U.S. Department
of Agriculture, Kenneth R. Bolen, Director of Cooperative
Extension, University of Nebraska, Institute and Natural
Resources.
Used with permission by Julie A. Albrecht, Cooperative Extension provides information and educational
Extension Food Specialist and Susan S. programs to all people without regard to race, color, national
Sumner, Extension Food Microbiologist. origina, sex or handicap.
Pictures Courtesy of Dianne Peters This poster is supported by the Extension Service U.S. Department
of Agriculture, under Special Project Number 92-EFSQ-1-4051
8

Call K-State Research and Extension, Value-


Added Foods Lab at: (785)532-1667, for
assistance and a personlized GMP's program.

References
Code of Federal Regulations (CFR), Part 110,
Subpart A-G.
cGMPs/ Food Plant Sanitation, Wilbur A. Gould,
Ph.D., CTI Publications, 1990.

Brand names appearing in this publication are for product identification purposes only. No endorsement is intended,
nor is criticism implied of similar products not mentioned.
Publications from Kansas State University are available on the World Wide Web at: http://www.oznet.ksu.edu
Contents of this publication may be freely reproduced for educational purposes. All other rights reserved. In each case, credit Fadi Aramouni, Ph.D., Extension
Specialist, Food Systems, Current Good Manufacturing Practices (cGMPs), Kansas State University, June 2001

Kansas State University Agricultural Experiment Station and Cooperative Extension Service
MF-2505 JUNE 2001
It is the policy of Kansas State University Agricultural Experiment Station and Cooperative Extension Service that all persons shall have equal opportunity
and access to its educational programs, services, activities, and materials without regard to race, color, religion, national origin, sex, age or disability.
Kansas State University is an equal opportunity organization. Issued in furtherance of Cooperative Extension Work, Acts of May 8 and June 30, 1914, as
amended. Kansas State University, County Extension Councils, Extension Districts, and United States Department of Agriculture Cooperating, Marc A.
Johnson, Director.

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