Part
V: Securing a Physical Plant
The final rule distinguishes the manufacturers
physical plant as:
All or any part of a building or facility that is used or linked
to manufacturing, packaging, labeling or holding a dietary supplement
Guidelines for securing a Physical
Plant: Cleaning of the Plant
Plants are required to be kept in a clean and sanitary state
at all times
Cleaning materials must be safe sanitizing compounds that
are free of toxic materials and do not pose a public health
risk
Guidelines for securing a Physical
Plant: Design of the Plant
Be appropriate in size, construction and design to accommodate
all plant operations
Have enough space for equipment storage and materials
Be designed in manner that prevents contamination of any kind
Must use inventory controls or automated systems of separation
All floors, walls, ceilings must be properly cleaned and repaired
All fixtures, ducts, pipes, air ventilation systems, filters,
fans or other environmental control equipment must not contaminate
any area
Must use safety light bulbs or fixtures that will protect
the plant from contamination in light fracture or breakage
Guidelines for securing a Physical
Plant: Plumbing
Must be able to consistently carry adequate amounts of water
to required locations around the plant
Must be able to dispose sewage and liquid waste of the plant
Cannot be a source of contamination to components, dietary
supplements, working surfaces, water supplies or any unsanitary
condition
Must provide proper drainage as needed in areas that require
flood-type cleaning or where there may be water discharges
Piping systems must not allow leaks or exposure of any kind
Guidelines for securing a Physical
Plant: Exterior Surroundings
Requires each company to maintain grounds surrounding the
physical plant to protect against contamination
If surrounding plant areas are not properly taken care of,
companies must inspect, exterminate and eliminate pests or
other materials accordingly
Guidelines for securing a Physical
Plant: Sanitation
Manufacturers must monitor their use of water in a dietary
supplement and comply with Federal, State and local community
standards to not contaminate the supplement
Water not used as part of a dietary supplement is required
to be safe, hygienic and dispensable at appropriate temperatures
Companies must properly maintain roads, yards and parking
areas to not be a source for exposure and contamination of
a dietary supplement
Areas filled with contamination must be drained, which is
not limited to sewage, filth or other materials that may create
an infestation
A waste management system must be in place to prevent contamination
Equipment must be appropriately stowed away to avert accidents
Litter and waste must be removed as needed to avoid contamination
Maintenance of grass, trees or weeds must be done properly
to not attract pests
No animals or pests are allowed in any area of a physical
plant at any time
Guard dogs are allowed in some areas of the plant that are
ensured of no contamination threat to any area
Disallows the use of pesticides, fumigants, rodenticides or
insecticides unless proper precautions are taken to eliminate
any threat of contamination in any area
Bathrooms must be adequate and readily accessible without
being a source of contamination
Hand washing stations must be available for usage on-site
and cannot be a source of contamination
Manufacturers must designate one or more employees to supervise
overall sanitation in their plants
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