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QUALITY INGREDIENTS
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BACK< CGMP DEMYSTIFIED

cGMP Demystified:
PART TITLE
I
The Overview
II
Written Procedures And Record Keeping
III
Quality Control Procedures

IV

V
Securing a Physical Plant
VI
Safe Equipment & Utensils
VII
Holding Dietary Supplements
VIII
Establishing a Production and Process Control System
IX
X
XI
XII
XIII
XIV
XV
For information on cGMPs, please visit: www.fda.gov.
Part V: Securing a Physical Plant

The final rule distinguishes the manufacturer’s “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