Cosmetics GMP Audit Checklist
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Auditor Name: Audit Date:
Facility Identifier: Audit Report Number:
Facility Location: Facility Production Type:
Facility Contact Name: Facility Contact Number:
Audited Requirement Rating Notes
Building and Facilities
Building(s) are of suitable size, design and construction.
Areas including equipment and storage areas have su cient space for operations.
Floors, walls, and ceilings are made of smooth and easily cleaned materials.
Building and facilities are maintained in good repair.
Fixtures, ducts, and pipes do not pose condensation dripping concerns over
production or storage of product.
Lighting is adequate for maintaining clean and safe operations.
Ventilation is su cient for operations and team member comfort.
Water supply and all related facilities including drainage is adequate for maintaining
operations and clean facilities.
Equipment
Equipment and utensils design, materials, and use prevent corrosion, adulteration
of product (lubricants, sanitizing agents, etc), or buildup of materials.
All utensils, equipment, and cosmetic product contact areas are maintained in
sanitary conditions.
Portable equipment or contact surfaces are su ciently cleaned, stored, and
covered to avoid contamination.
Personnel
Personnel are appropriately trained/educated/experienced for their roles and
responsibilities within the manufacturing and control aspects of production.
Personnel who come into contact or close contact with products shall wear the
appropriate personal protective equipment to maintain cleanliness and prevent
d t t i ti d lt ti
Personnel only consume food, drink, inhalants or other items in designated areas
only and never in the production environment.
Raw Materials
Raw materials and packaging are stored appropriately with the proper labelling to
avoid potential mix-ups.
Raw materials and primary packaging are stored and handled in a way to prevent
contamination or adulteration.
Materials containers are stored in a closed/sealed state to avoid contamination. No
product packaging or materials are stored directly on the floor.
Material labels include material identity, lot information, and control status.
Materials are subject to sample testing to ensure end product e cacy and prevent
contamination.
A process is in place for labelling, separating, and storing/handling materials that
fail sample testing to avoid mixing with other materials or product.
Production
All equipment, conveyors, utensils, storage vats, and other items that contact
materials or product are clean, sanitary, and well-maintained.
Only approved, sampled, tested, and certified materials are used in production.
Samples are tested at the appropriate stages of production and at an appropriate
frequency to su ciently prevent product contamination or adulteration.
Raw material weights and measures are verified via primary and witness personnel.
All storage vessels, tanks, containers, vats, and other holding containers for raw
materials and product are properly labelled.
All major equipment and transfer lines are appropriately labelled.
Labels are always double-checked against product/materials to avoid labelling
mix-up.
Equipment for processing, holding, transferring, or filling are labelled with identity,
batch information and control status.
Permanent code marks exist on packages of all finished products.
Returned cosmetics are examined and documented to determine if any
deterioration or contamination occured.
Laboratory Controls
Raw materials, finished products, and in-process samples are tested/reviewed for
identification verification, contaminants, and compliance to specifications.
Sample reserves are held appropriately for the designated time, stored to prevent
contamination or adulteration.
Any water used in production as an ingredient is routinely tested for contaminants
and purity.
Fresh and retained samples are tested for preservation adequacy to ensure end
user product e cacy and safety.
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Cosmetics GMP Audit Checklist
Customize this template on your device with the 1st Reporting App.
Go to 1stReporting.com to learn more.
Auditor Name: Audit Date:
Facility Identifier: Audit Report Number:
Facility Location: Facility Production Type:
Facility Contact Name: Facility Contact Number:
Audited Requirement Rating Notes
Records
Raw material documentation is maintained and accessible.
Primary packaging documentation is maintained and accessible.
Batch documentation of the kind, lot, and quantity of materials is maintained and
accessible.
Processing, handling, transferring, holding, and filling documentation is maintained
and available.
Sampling, controlling, adjusting, and reworking documentation is maintained and
accessible.
Batch code marks and finished product code marks records are maintained and
accessible.
Sampling and testing results of finished products and samples are documented,
maintained, and accessible.
Laboratory controls and control status documentation is maintained and
accessible.
Distribution, shipments, code marks, and consignee documentation is maintained
and accessible.
Labeling
The principle display label panel includes the name of the product, statements of
identity, and net contents.
The principle display label panel includes the statement "Warning--The safety of
this product has not been determined." if safety is unsubstantiated.
The information panel label includes the name and address of the manufacturer.
The information panel label includes the list of ingredients if the product is
intended for sale or sold to consumers for consumption at home.
The information panel label includes any warning states as required at 21 CFR
740.11, 740.12 and 740.17.
The information panel label includes any additional warnings to prevent a health
hazard.
The information panel label includes directions for safe product use.
The information panel label includes any directions or information for patch testing
(hair dye) as per Sec. 601(a) of the Act.
Complaints
A complaint file or means of managing and documenting reports of complaints is
maintained and accessible (a complaint management system is in place).
The complaint system records the kind and severity of each reported injury,
including position on the body of injury.
The complaint system records the product associated including manufacturer and
code number.
The complaint system records the medical treatments administered, if applicable,
as a result of the product causing injury, including facility and name of attending
medical personnel.
The complaint system records any further involvement by agencies or facilities,
including names and locations (poison control, physicians o ce, walk-in clinic, etc).
Other Items
Does the facility participate in voluntary registration of Cosmetic manufacturing
extablishments (21 CFR 710)?
Does the facility participate in voluntary registration of Cosmetic product
ingredient and cosmetic raw material comsumption statements (21 CFR 720)?
Is the facility using a color additive not listed for use in cosmetics or not certified
for the intended use (21 CFR 73, 74, 82 and 21 CFR 80)?
Is the facility using a prohibited cosmetic ingredient (21 CFR 700)?
Notes
Signature of Auditor: Date:
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