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: [email protected]
Phone: 706-542-2574
For more info, please visit out website at:
fste.uga.edu
*Prices subject to change at anytime