GMP Manual for Dietary
Company recognizes its responsibility as a producer of
quality products. To this end, XYZ Company has
quality management system to better satisfy the needs of its customers
improve management of the business. The management
system complies with the Code of Federal Regulations, Title
21, Part 111
(21 CFR Part 111) - Current Good Manufacturing Practice in
Packaging, Labeling, or Holding Operations for Dietary Supplements.
system also complies
with the international standard ISO 22000:2005, Food safety management
– Requirements for any organization in the food chain.
manual has been prepared to define the quality management system,
responsibilities of the personnel affected by the system, and to
general procedures for all activities comprising the management
In addition, this manual is utilized for the purpose of informing our
of the management system and what specific controls are implemented to
quality and safe products.
manual will be revised as necessary to reflect the management system
in use. It is issued on a controlled copy basis to all
affected by the system and on an uncontrolled copy basis to
and suppliers, although it can be issued to customers on a controlled
basis upon customer request.
CONTROL OF DOCUMENTS
Company identifies and controls documents required by the quality
management system according to the Control of Documents
ensures that documents:
are reviewed and approved for adequacy
prior to issue;
are updated, reviewed, and approved for
re-issue as necessary;
are identified with their current
are available at point of use;
are legible, readily identifiable, and
of external origin are identified and
their distribution is managed;
that are obsolete are prevented from
unintended use and are suitably identified if they are retained for any
defined as records are managed per the Control of Records
XYZ Company’s management provides evidence
of its commitment to the
development, implementation, and continual improvement of the
quality management system.
XYZ Company shall provide
adequate resources for the establishment, implementation, maintenance
and updating of the quality management system.
management is committed to provide adequate resources to implement and
improve the processes of the quality management system and promote customer satisfaction. The quality
safety team and the other personnel carrying out activities having an
impact on product quality and safety are competent and have
training, skills, and experience.
assistance of external experts is required for the development,
implementation, operation, or assessment of the quality management
system, records of agreement or contracts defining the responsibility
and authority of external experts are available.
For details, refer to the Control
of Records Procedure.
resources for implementation and improvement of the quality
management system and for addressing customer satisfaction may
include any of the following: information,
employees, external experts, infrastructure, work environment, and
financial funds. The
principal means for determining and communicating resource requirements
are management reviews of the quality management system. For details, refer to the Management
The quality and
manager and all management personnel affected by the quality
management system are responsible for determining resource requirements
for the implementation and improvement of the system.
Resources for designated activities are
integrated with the process of defining and initiating the activity. They may take the form of
personnel assignments, allocation of space or equipment, training,
procurement decisions, budgets, etc.
personnel that are responsible for identifying sanitation failures or
product contamination have a background of education or experience, or
combination thereof, to provide a level of competency necessary for
production of clean and safe products.
Product handlers and supervisors receive
appropriate training in proper handling techniques and
product-protection principles and are informed of the danger of poor
personal hygiene and unsanitary practices.
PRODUCTION AND PROCESS CONTROLS
XYZ Company has established and
maintains documented plans and procedures to ensure that processes and
sub-processes are conducted under controlled conditions and yield safe
of the production processes is consistent with the other requirements
of XYZ Company’s quality management system.
Quality and Safety Team
XYZ Company has appointed a quality
and safety team.
and safety team is comprised of multi-disciplinary members that posses
the required knowledge and experience in developing and implementing
the quality management system. This includes, but is
limited to, XYZ Company’s products, processes, equipment, and product
safety hazards within the scope of the quality management system.
that demonstrate that the quality and safety team has the required
skills, and experience are maintained per the Control of
Prevention of Cross Contamination
The material contact containers and material
handling equipment are cleaned prior to use in production. Utensils
and equipment that have come in contact with the floor, waste or other unsanitary objects are
cleaned prior to making contact with product.
Employees, equipment, utensils and
protective garments that are utilized for raw material are not utilized
for finished products. Employees
working in production and storage areas are not permitted to work in
packaging and labeling areas. In
the event it will be necessary to transfer the employee into these
areas, they will first clean and sanitize their hands and change their
outer garments. Hand-washing stations and hand dips at the start
and end of each process line are maintained.
Employees are trained in how to properly wash
and sanitize. The
training is documented
and records are stored on file.
containers are not left open to prevent contamination with in-process
and finished product.
The production of one product is kept separate from the
production of other products. Before
starting production of a different product,
the floor and all applicable workstations and equipment
are properly cleaned and sanitized.
utensils, buckets and containers are maintained for different products in
usage. Should any
form of waste or floor splash contaminate the process line, the
production supervisor/manager will immediately stop the process line. The section affected will
be cleaned, sanitized and inspected before production is restarted.
to sending completed product to packaging and
labeling, all containers are thoroughly cleaned externally to prevent
Handling, Storage, Packaging, Labeling, Preservation, and Transportation
ensures that incoming
material (i.e., raw material, ingredients, packaging material,
returned finished product, etc.) are transported, received, stored and
handled in a
manner to prevent chemical, physical or microbiological contamination
of products. Incoming
materials are received in an area separate from processing area(s).
Raw materials are washed or cleaned as
necessary to remove soil or other contamination.
Effective measures are taken by XYZ
Company to prevent contamination of raw materials, ingredients and
packaging materials. The XYZ Company does not accept
incoming materials if they are known to be contaminated with the
- toxic substances
- undesirable microorganisms
- decomposed or extraneous
Incoming materials that require
refrigeration are stored at regulated and/or acceptable temperatures
and are appropriately monitored. If
thawing is required prior to use, it is done in a manner that prevents
the materials from becoming adulterated.
Incoming materials that are sensitive
to humidity are stored under appropriate conditions to prevent
and dry raw materials and other ingredients that are received and
stored in bulk form are stored in a manner that protects against