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Audit

Building and Facilities

Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.

Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair.

Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk.

Lighting and ventilation are sufficient for the intended operation and comfort of personnel.

Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.

Equipment

Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitizing agent.

Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitized at appropriate intervals.

Cleaned and sanitized portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination.

Personnel

The personnel supervising or performing the manufacture or control of cosmetics has the education, training and/or experience to perform the assigned functions.

Persons coming into direct contact with cosmetic materials, finished products in bulk or cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garments, gloves, hair restraints etc., and maintain adequate personal cleanliness.

Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas.

Raw Materials

Raw materials and primary packaging materials are stored and handled in a manner which prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture.

Containers of materials are closed, and bagged or boxed materials are stored off the floor.

Containers of materials are labeled with respect to identity, lot identification and control status.

Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms.

Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics.

Production

The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition.

Only approved materials are used.

Samples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microorganisms or chemical contaminants, and compliance with any other acceptance specification.

Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified.

Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information.

Labels are examined for identity before labeling operations to avoid mix-up.

The equipment for processing, holding, transferring and filling of batch is labeled regarding identity, batch identification and control status.

Packages of finished products bear permanent code marks.

Returned cosmetics are examined for deterioration or contamination.

Laboratory Controls

Raw materials, in-process samples and finished products are tested or examined to verify their identity and determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants.

Reserve samples of approved lots or batches of raw materials and finished products are retained for the specified time period, are stored under conditions that protect them from contamination or deterioration, and are retested for continued compliance with established acceptance specifications.

The water supply, particularly the water used as a cosmetic ingredient, is tested regularly for conformance with chemical-analytical and microbiological specifications.

Fresh as well as retained samples of finished products are tested for adequacy of preservation against microbial contamination which may occur user reasonably foreseeable condition of storage and consumer use.

Records

Raw materials and primary packaging materials, documenting disposition of rejected materials.

Manufacturing of batches, documenting the:
- Kinds, lots and quantities of material used
- Processing, handling, transferring, holding and filling
- Sampling, controlling, adjusting and reworking
- Code marks of batches and finished products

Finished products, documenting sampling, individual laboratory controls, test results and control status.

Distribution, documenting initial interstate shipment, code marks and consignees.

Labeling

On the principal display panel:
In addition to the name of the product, the statements of identity and net contents,
The statement "Warning--The safety of this product has not been determined" if the safety of the respective product has not adequately been substantiated.
Determine whether and what toxicological and/or other testing the firm has conducted to substantiate the safety of its products

On the information panel:
- The name and address of the firm manufacturing the product or introducing it into interstate commerce.
- The list of ingredients (only on outer container) if intended for sale or customarily sold to consumers for consumption at home.
- Any other warning statement necessary or appropriate to prevent a health hazard.
- Determine the health hazard or their basis for a warning statement.
- Any direction for safe use of product. In case of a hair dye product, appropriate directions for preliminary patch testing.
- This warning only applies to coal-tar hair dyes which, if so labeled, are then exempted from the adulteration provision of the Act.

Complaints

The kind and severity of each reported injury and the body part involved.

The product associated with each injury, including the manufacturer and code number.

The medical treatment involved, if any, including the name of the attending physician.

The name(s) and location(s) of any poison control center, government agency, physician's group etc., to whom formula information and/or toxicity data are provided.

Other

Participating in the program of voluntary registration of cosmetic manufacturing establishments; cosmetic product ingredient and cosmetic raw material composition statements

Using a color additive which is only listed for use in cosmetics or which is certified.

Using approved cosmetic ingredients

Completion
Full Name and Signature

FDA GMP Cosmetics Audit Checklist

Created by: SafetyCulture Staff | Industry: General | Downloads: 185

This digital GMP Cosmetics Checklist has been built using the iAuditor app and based on the FDA’s GMP Cosmetic Guidelines. Use this digital GMP checklist to assess your manufacturing compliance with FDA guidelines across aspects of building and facilities, equipment, personnel, raw materials, production, lab controls, record keeping, labelling and complaints. Use iAuditor to take notes and photo evidence of non-compliance. Automatically calculate your audit score based on the responses and generate a complete report without leaving your manufacturing facility. Save all your reports securely in the cloud.

Signup for a free iAuditor account to download and edit this checklist. It will be added to your free account and you will be able to conduct inspections from your mobile device.

Download and edit this free checklist

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Audit

Building and Facilities

Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.

Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair.

Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk.

Lighting and ventilation are sufficient for the intended operation and comfort of personnel.

Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.

Equipment

Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitizing agent.

Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitized at appropriate intervals.

Cleaned and sanitized portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination.

Personnel

The personnel supervising or performing the manufacture or control of cosmetics has the education, training and/or experience to perform the assigned functions.

Persons coming into direct contact with cosmetic materials, finished products in bulk or cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garments, gloves, hair restraints etc., and maintain adequate personal cleanliness.

Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas.

Raw Materials

Raw materials and primary packaging materials are stored and handled in a manner which prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture.

Containers of materials are closed, and bagged or boxed materials are stored off the floor.

Containers of materials are labeled with respect to identity, lot identification and control status.

Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms.

Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics.

Production

The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition.

Only approved materials are used.

Samples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microorganisms or chemical contaminants, and compliance with any other acceptance specification.

Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified.

Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information.

Labels are examined for identity before labeling operations to avoid mix-up.

The equipment for processing, holding, transferring and filling of batch is labeled regarding identity, batch identification and control status.

Packages of finished products bear permanent code marks.

Returned cosmetics are examined for deterioration or contamination.

Laboratory Controls

Raw materials, in-process samples and finished products are tested or examined to verify their identity and determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants.

Reserve samples of approved lots or batches of raw materials and finished products are retained for the specified time period, are stored under conditions that protect them from contamination or deterioration, and are retested for continued compliance with established acceptance specifications.

The water supply, particularly the water used as a cosmetic ingredient, is tested regularly for conformance with chemical-analytical and microbiological specifications.

Fresh as well as retained samples of finished products are tested for adequacy of preservation against microbial contamination which may occur user reasonably foreseeable condition of storage and consumer use.

Records

Raw materials and primary packaging materials, documenting disposition of rejected materials.

Manufacturing of batches, documenting the:
- Kinds, lots and quantities of material used
- Processing, handling, transferring, holding and filling
- Sampling, controlling, adjusting and reworking
- Code marks of batches and finished products

Finished products, documenting sampling, individual laboratory controls, test results and control status.

Distribution, documenting initial interstate shipment, code marks and consignees.

Labeling

On the principal display panel:
In addition to the name of the product, the statements of identity and net contents,
The statement "Warning--The safety of this product has not been determined" if the safety of the respective product has not adequately been substantiated.
Determine whether and what toxicological and/or other testing the firm has conducted to substantiate the safety of its products

On the information panel:
- The name and address of the firm manufacturing the product or introducing it into interstate commerce.
- The list of ingredients (only on outer container) if intended for sale or customarily sold to consumers for consumption at home.
- Any other warning statement necessary or appropriate to prevent a health hazard.
- Determine the health hazard or their basis for a warning statement.
- Any direction for safe use of product. In case of a hair dye product, appropriate directions for preliminary patch testing.
- This warning only applies to coal-tar hair dyes which, if so labeled, are then exempted from the adulteration provision of the Act.

Complaints

The kind and severity of each reported injury and the body part involved.

The product associated with each injury, including the manufacturer and code number.

The medical treatment involved, if any, including the name of the attending physician.

The name(s) and location(s) of any poison control center, government agency, physician's group etc., to whom formula information and/or toxicity data are provided.

Other

Participating in the program of voluntary registration of cosmetic manufacturing establishments; cosmetic product ingredient and cosmetic raw material composition statements

Using a color additive which is only listed for use in cosmetics or which is certified.

Using approved cosmetic ingredients

Completion
Full Name and Signature