Part
VI: Safe Equipment & Utensils
Introduction
To operate a cGMP certified plant, manufacturers must
have the proper tools available. These guidelines apply to any
utensils and automatic, mechanical or electronic equipment.
As part of the Final Rule, quality control personnel must also
calibrate, maintain, clean, sanitize and check all equipment,
utensils and surfaces used during any processes. To ensure cGMP
compliance, the FDA requires all those who manufacture dietary
supplements have safe and appropriate equipment and utensils.
Guidelines for Safe Equipment &
Utensils: Specifications
All equipment and utensils must be of appropriate design, construction
and workmanship to be suitable for use and must be properly
clean and maintained
Properly designed and constructed equipment, which does not
contain lubricants, fuel, coolants, metal and glass, filth,
contaminated water or other pollutants is neccessary
Equipment and utensils must facilitate cleaning, be made of
non-toxic materials, be able to endure maintenance and should
protect against contamination from another source
Seams of materials and utensils must be free of dirt, filth
or other organic materials
Guidelines for Safe Equipment
& Utensils: Temperature Storage
Temperature holding compartments such as freezers, refrigerators
or other cold storage must be fitted with a temperature device
and an automated device to regulate temperature
Temperature compartments and controls must not inhibit contaminants
and must be maintained
Guidelines for Safe Equipment
& Utensils: Calibration
Instruments and controls must be calibrated before first use
and at the frequency specified by the manufacturer or by routine
intervals
Utensils and equipment that cannot be adjusted to the proper
reference standard must be repaired or replaced
Guidelines for Safe Equipment
& Utensils: Sanitation
Equipment and utensils are required to be maintained, cleaned
and sanitized as necessary, in addition to all contact surfaces
Disassembly of equipment is also necessary when cleaning,
maintaining or sanitizing
Contact surfaces used for manufacturing or holding of components
or dietary supplements must be kept in a dry and sanitary
state when used
Areas must be thoroughly clean and sanitized if there is wet
processing during manufacturing to prevent contamination
All contact surfaces must be clean and sanitized before use
or during any time contamination occurs
Continuous operation of products including different batches
requires cleaning and maintenance as needed
Areas that have indirect contact to components or dietary
supplements must also be cleaned to prevent contamination
One time use products such as cups, towels or paper must be
stored and dispensed properly
Cleaning and sanitizing materials must be deemed adequate
and safe for usage on equipment and utensils
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