GOOD MANUFACTURING

PRACTICES/PREVENTATIVE CONTROLS

Anand Mohan, Ph.D.

Associate Professor and Extension Specialist

Derell Hardman, M.S.

Program Coordinator, Technical Services

Good Manufacturing Practices (GMPs)

• GMPs refer to all practices that are used to prevent and protect food from

hazards.

• Food Safety Hazards

• Any foreign material or material that could cause

injury to the consumer health.

Source: complianceonline.com

Good Manufacturing Practices (GMPs)

• 21CFR Part 110/117: GMPs in manufacturing, packing, or holding human

food

• “A food shall be deemed to be adulterated if it has been prepared,

packed or held under insanitary conditions whereby it may have

become contaminated with filth, or whereby it may have been rendered

injurious to health.”

FDA/GDA’s Responsibility Food Industry’s Responsibility

To provide oversight to the food industry

leading to the implementation of GMPs

To ensure that food is prepared, packaged,

and stored under sanitary conditions

Why do GMPs matter?

• It’s not necessary for the regulatory agency to provethat a food is contaminated, or is injurious to health to declare it adulterated.

• It would only need to be shown that the food was manufactured, packed, or held under insanitary conditions.

Visible mold

growth or

microbial

contamination

Insects (vermin)

dead or alive

fda.gov

Good Manufacturing Practices (GMPs)

GMPs provide for the following:

• Facility design

• General maintenance of physical facilities

• Cleaning and sanitizing of equipment and utensils

• Pest control

• Proper use and storage of cleaning products, sanitizers, and

pesticides

• Employee health, hygiene, and training

• Process Controls

• Establishment of a scheduled process

• Record-keeping

Building and Facilities• The grounds about a facility under the control of the

operator shall be kept in a condition that will protect food

from the contamination.

• Properly storing equipment and materials

• Removing waste/trash.

• Maintaining roads, yards, and parking lots

• Adequate drainage.

• Adequate lighting in hand-washing areas, dressing and

locker rooms, toilet rooms, and in all areas where food

is examined, processed, or stored.

• Screening or protection against pests.

• Prevent drip or condensate from contaminating product.

Equipment and Utensils

• Must be designed so that all food contact surfaces are smooth and readily accessible for cleaning and sanitizing.

• Even non-contact surfaces must be cleaned so extraneous matter and microbes can’t build up and contaminate the food.

Production and Process Controls for Acidified Foods

• The manufacturer shall employ appropriate quality

control procedures to ensure that finished foods do not

present a health hazard.

• Acidified foods shall be so manufactured, processed,

and packaged that a finished equilibrium pH value of 4.6

or lower is achieved

• Frequent testing and recording of results shall be exercised so

that the finished equilibrium pH values for acidified foods are not

higher than 4.6

• Each container or product shall be marked with an

identifying code permanently visible to the naked eye.

Establishing a Scheduled Process for Acidified Foods

Process Authority

• The scheduled process shall be established by a qualified person who

has expert knowledge acquired through appropriate training and

experience in the acidification and processing of acidified foods.

The process as approved must be filed with the FDA and must

be followed as approved.

Records and Reports• Records shall be maintained of examinations of raw materials,

packaging materials, and finished products, and of suppliers' guarantees or certifications

• Processing and production records showing adherence to scheduled processes shall be maintained

• pH measurements and other critical factors

• All departures from scheduled processes having a possible bearing on public health or the safety of the food shall be noted and the affected portion of the product identified

• Copies of all records shall be retained at the processing facility or other reasonably accessible locations for 3 years from date of manufacture

FOOD SAFETY REQUIREMENTS

FOR ACID/ACIDIFIED FOODS

Acidified Food Regulation (21CFR Part 114)

• Written to specifically to protect the food supply from growth

and toxin production by Clostridium botulinum

• Cannot grow and produce its deadly toxin at pH 4.6 and below

• Certain other pathogenic bacteria, such as E. coli and Salmonella can

grow in foods at pH below 4.6

• It’s important to not depend only on pH to assure food safety.

“Acidified foods shall be thermally processed to an extent that is

sufficient to destroy the vegetative cells of microorganisms of public

health significance and those of non-health significance capable of

reproducing in the food under the conditions in which the food is stored,

distributed, retailed and held by the user.

Clostridium botulinum

Inadequate/Under Processing

• Improper pasteurization or not achieving the correct

time/temperature combination during processing can

leave pathogens and spoilage microorganisms in the

food

• Yeasts and molds are more acid-tolerant and can survive

and grow at a lower pH

• Their growth can lead to an increase in pH to above 4.6

Potential Hazards and Their Controls

• What is a Hazard?

• A biological, chemical or

physical agent that is

reasonably likely to cause

illness or injury in the absence

of its control

Hazards

Biological

Chemical

Physical

What is a Biological Hazard?

• Biological hazards include microorganisms such as bacteria, viruses,

yeasts, molds and parasites. Some of these are pathogens or may

produce toxins. A pathogenic microorganism causes disease and can

vary in the degree of severity.

• Salmonella, E. coli and Clostridium botulinum.

C. botulinum, cdc.govSalmonella, cdc.gov

E. coli, niaid.nih.gov

Microbial Spoilage

• Poor Quality In = Poor Quality Out

• Bad quality raw ingredients can increase

the onset of spoilage.

• High initial amount of spoilage microbes

can render scheduled process ineffective.

• Heavy spoilage growth can increase

the pH to an unsafe level (>4.6).

Preventative Measures for Spoilage

• There are several ways to prevent spoilage of acidified foods

• Adequate thermal processes

• Rapid cooling

• Proper sanitation practices

• Recipes that combine several organic acids (citric acid, lactic acid,

etc.) and chemical preservatives (sodium benzoate and potassium

sorbate) at various concentrations

• Maintain a hermetic seal in containers

Acid-tolerant Pathogens

•Acid-adapted bacteria such

as Salmonella, Escherichia coli O157:H7, and Listeria

monocytogenes can survive in a highly acidic

environment (as low as pH 2.5)

•Exposure to acids during food processing or storage

enhances acid tolerance, thus ensuring bacteria safe

transit through the stomach during foodborne

infection.

Sources of Physical Hazards

•Contaminated raw materials

•Poorly designed or

maintained equipment

•Faulty production procedures

• Improper employee practicesAlimenti Food Sciences

Sharp black metal fragments

in Walmart donut, 8.27.13

SERVICES AND FORMS

Services We (UGA Food Science) Provide

•Process Approval

•Product Classification

•Nutrition Facts Panel

•Product Testing

•pH, Water activity, Brix

•Shelf-life Study

•Training on Food Safety, Sanitation, and Auditing

Step by Step Instructions:

Process Approval

• Contact Info

• Type your information directly into

our fillable PDF form

• Complete contact information

prevents delays in getting your

process approval!

• You should save this form to your

computer – put the name of the

product, your name and date in the

file name to make it easier to find.

Recipe for the Product

• Enter the recipe for one BATCH

(not an individual) as you would

make it

• Be accurate with your amounts

and units of measure

Acidifier & pH

• Test the pH of your acidifier

before making each batch to

prevent high pH numbers later!

• The pH may vary between brands

of vinegars or other acidifiers.

• pH testing is included in your

Process Approval fee

Thermal Processing:

Cooking or Heating the Product

• If you cook or heat product before canning, what method do you use?

• Measure temperature with a calibrated thermometer at geometric center

• Fill temperature at which you are filling your jar

• How long can the product hold at least 180F temperature?

Containers

Closures / Caps

• Closures / Caps• Different ways

of product container to be sealed?

• Assures the customer that the product is not tampered with?

Taking Temperature Measurements

• Use a calibrated thermometer to take temperature readings (see your thermometer’s manufacturer’s directions for the proper method)

• Insert probe or tip of thermometer near the “geometric center” of your jar or pot to get the most accurate reading

• Do not allow probe or thermometer to touch sides of vessel or chunks of product

• Record your results on your record keeping form immediately

• Carefully wash and dry probe or thermometer after use, or before using in another product

Product

Classification

▪ Similar to

Process

Approval

▪ Contact

information and

ingredient list

Product

Classification

• Thermal

Processing is

different.

• We don’t need

hold time and

temperature.

Nutrition Facts Panel

▪ Ingredient information needs to

be complete. Every little detail

counts.

• Measure the raw ingredients

• Measure the batch after cooking

• Container size

Letter for Process Approvals and Product Classification

• Once the process approval

has been completed, a Letter

of Process Approval/Product

classification is sent by EFS

to you and the GDA.

• The documentation of your

process, along with pH testing

and any other testing

performed on your product, is

also kept on file.

Shelf-Life Study

• Accelerated Shelf-Life

Testing.

• We consult with you to learn

about your product, process,

and distribution.

• We design the study and

determine the number of

products we will need from you

and the time it will take.

Prices for the Services Offered

• Price per product*• Process Approval - $175

• Product Classification - $175

• Nutrition Facts Panel - $175• Additional Container Size - $40 each

• Product Testing - $30

• Shelf-Life Study - $350

• Product Label Review• UGA NFP - $50

• Non-UGA NFP - $75

• On-Site Training: Contact us for pricing

Please contact us to discuss our services!

Email: efs@uga.edu

Phone: 706-542-2574

For more info, please visit out website at:

fste.uga.edu

*Prices subject to change at anytime