GMP Manual
GMP Manual
GMP Manual
or Back
module 01 page 2 of 26
module 01 page 3 of 26
module 01 page 4 of 26
module 01 page 5 of 26
module 01 page 6 of 26
Flash Player
You will need a media player software called Flash Player installed on your computer to
view the interactive features throughout the course. Do not go forward until you have this
flash player.
You may already have this software. Look at the graphic below. The word GMPs
should be changing color. If it is changing color, you already have the correct software
installed on your computer and you can proceed.
GMPs
If you do not see the word GMPs changing colors and instead see the words SORRY:
You need to install Flash Player click on the link below and follow the instructions to
download Flash Player before you go any further.
Some of the most useful and instructive features of this course such as our GMP TV will
not work unless the Flash Player is installed on your computer. If your computer does not
have this software and your company has restrictions that prohibit the computer you are
using from downloading this software, it would be a good idea to ask for help now. It may
be possible to set up a computer with this common program or you may want to review
other options such as taking the course at another location where you can use Flash Player. Without this free software many important learning experiences provided in this course
will be missed.
module 01 page 7 of 26
Good Manufacturing Practices or GMPs describe the conditions and practices that are
necessary for the manufacturing, processing, packing or storage of food to ensure its
safety and wholesomeness.
GMP Regulation: GMPs are a set of federal regulations that apply to all food processors, distributors, and warehouses. They are the basis for determining whether the practices, conditions, and controls used to process, handle or store food products are safe and
whether the conditions in the facility are sanitary.
GMPs Set Minimum Standards: The GMP regulations are designed to be the minimum
standards for the food industry. GMPs are general in nature and do not prevent food processing and storage facilities from using manufacturing practices that exceed any provisions in the regulations.
GMPs Are General Guidelines: Because the GMP regulation is general in nature, it uses
words such as adequate, appropriate or as necessary. Each firm must develop and
implement procedures for each GMP requirement that will protect the food that they receive, store or process from contamination. These procedures are specific to each firm
since they are developed to meet the unique needs of the facility, food products, processes, and equipment. There may be many different strategies that are adequate or appropriate for different situations. The GMP is designed to provide this flexibility.
module 01 page 8 of 26
module 01 page 9 of 26
Definitions 110.3
Current Good
Manufacturing
Practices 110.5
Personnel 110.10
Disease Control
Cleanliness/Hygiene
Education & Training Supervision
Exclusions 110.19
F*
Subpart G:
Defect Action Levels
110.110
module 01 page 10 of 26
Definitions
The first part of the GMP regulation provides definitions and interpretations for key words
that are used throughout the regulation. These definitions can be found in Subpart A, Section 110.3 of the GMP regulation. You can review them at any time during this course by
clicking onto the
button at the top of your screen.
Some of these definitions describe what the FDA means by general terms such as: adequate, food, food contact surfaces, lot, microorganisms, pest, plant, quality control operation, re-work, and sanitize. Other definitions apply to specific types of food or processing activities such as: acid foods, batter, blanching, safe moisture level, and water activity
(Aw).
Two key definitions that you need to know about are the words Shall and Should, which
appear in many places in the GMP regulation. Lets review these definitions.
Shall is used to state mandatory requirements. In other words, if the GMP regulation says
that something shall be done, this means you must do it to comply with the requirements of the GMP.
Should is used to state recommended or advisory procedures or to identify recommended
equipment. In other words, if the GMP regulation says that something should be done,
the agency believes that it is a good practice that will help you meet the requirements
of the GMP, but it is not required.
Take a few minutes to review these definitions by clicking on the GMP regulation button
above and then click on the words Definitions 110.3. Use your browsers back button to
return to this page.
module 01 page 11 of 26
module 01 page 12 of 26
(a) The criteria and definitions in this part shall apply in determining whether
a food is adulterated (1) within the meaning of section 402 (a) (3) of the act in that
the food has been manufactured under conditions that it is unfit for food; or (2) within the meaning of section 402 (a) (4) of the act in that the food has been prepared,
packed, or held under insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have become injurious to health. The criteria and definitions in this part also apply in determining whether the food is in violation of section
361 of the Public Health Service Act (42 U.S.C. 264).
In this part of the regulation, the current laws that provide the authority that regulatory
agencies need to enforce the GMPs are identified.
Definiton of Adulterated Food: This section of the regulation also says that the definitions and conditions that are described in the current GMP regulation will provide the basis
for the FDA to determine if a food is adulterated or unfit for human consumption. It identifies two ways that a food can become adulterated.
1. By being manufactured under conditions that make it unfit for food, or
2. By being prepared, packed, or held under insanitary conditions that may cause the
food to become contaminated with filth or become injurious to health.
Failure To Comply: Failure to meet the requirements of the GMP regulation could lead to
either of these two conditions and cause food to be considered adulterated and unfit for
human consumption. If that happens, you could be faced with regulatory action including
seizure, injunction or even prosecution.
module 01 page 13 of 26
Exclusions
GMP Reguirement: Exclusions 110.19
(a) The following operations are not subject to the GMP: Establishments engaged solely in the harvesting, storage, or distribution of one or more raw
agricultural commodities as defined in section 201(r) of the act, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the
consuming public.
(b) FDA, however, will issue special regulations if it is necessary to cover these excluded operations.
Exclusions: This section of the general provisions of the GMP describes what type of operations are excluded and do not have to follow the requirements of the GMP regulation. It
also gives the FDA the authority to develop special regulations for these firms if they are
determined to be necessary.
Raw Agricultural Commodity means any food in its raw or natural state, including all
fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior
to marketing. This definition is intended to allow producers of foods such as farmers who
store and/or transport raw foods to be exempted from the GMP regulation. However, processors, distributors, or storage facilities that receive these raw foods, are covered by the
GMPs.
module 01 page 14 of 26
module 01 page 15 of 26
module 01 page 16 of 26
module 01 page 17 of 26
module 01 page 18 of 26
module 01 page 19 of 26
Cutting boards will be cleaned with Grease B Gone detergent and sanitized
with a 100 PPM solution of chlorine sanitizer at the end of each day.
module 01 page 20 of 26
module
page 19
module
0101 page
21 of 26
Managers Role
Diverse Responsibilities: Company managers have an important role in the firms food safety and sanitation program.
Managers must run the business, work with customers, sell
your products, purchase raw materials and ingredients, and
make sure that the firm meets all of the regulations associated with your business. This is a big responsibility.
Managers and GMPs: One of the managers most important
responsibilities is to make sure that your facility follows the
GMPs. Managers need to make sure that the building and its
facilities are suitable for the processing and handling activities
that are conducted and for the proper storage of your food.
Managers must also provide all of the equipment and tools
needed to comply with the GMPs, and make sure they are are
available and appropriate for their intended use.
Policies and Training: Company managers should also play a key role in the development, implementation, and enforcement of policies that make sure that employees are
properly trained and their practices meet the requirements of the GMPs.
module
page 19
module
0101 page
22 of 26
Managers Role
Support and Guidance: All companies should have programs that recognize the importance of GMPs. Managers must also provide the guidance and support necessary for all
employees to meet GMP requirements. Producing safe food and complying with GMPs is a
team effort.
Key Roles: Lets review some of the key roles that company managers can play in helping your firm meet GMP requirements.
1. Provide the building, facility, and equipment that is needed and the resources needed
to manage and maintain them.
2. Actively support the companys GMP and sanitation program.
3. Help develop and implement the companys sanitation procedures.
4. Develop, implement, and enforce policies that ensure compliance with GMPs.
5. Review sanitation and GMP programs and develop and implement changes when
needed.
6. Develop, review, and manage records that show that the company complies with
GMPs.
7. Support and participate in employee training programs.
module
page 19
module
0101 page
23 of 26
Supervisors Role
Oversight: People who have oversight responsibilities for certain
areas of the plant, production activities, or groups of employees
are generally referred to as supervisors. These people are often
responsible for making sure that things get done properly and on
time. They usually are also responsible for making sure that all
GMP requirements associated with the area, process, or the employees that they supervise are met.
Training: Supervisors should actively work with their employees
as well as plant managers to make sure that everyone understands
what is expected, why it is important, and what the consequences
of failure are. For this reason, supervisors play a key role in training plant workers and making the companys sanitation procedures
work effectively.
Key Roles: Lets review some of the key roles that all supervisors
can play in helping your firm meet GMP requirements.
1. Help develop and deliver employee training programs.
2. Help develop and implement the companys sanitation procedures.
3. Monitor and keep records that demonstrate the use of good sanitation practices.
4. Coordinate and conduct any corrections needed to fix problems and keep records of
the actions that are taken.
5. Review and suggest revisions to the sanitation program as needed or at least once
per year.
module 01 page 24 of 26
module 01 page 25 of 26
module 01 page 26 of 26