GMP Audit Checklist for Cosmetics

Use the GMP Audit Checklist for Cosmetics to ensure adherence to GMP standards through inspections of buildings, facilities, equipment, personnel, etc.

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Manufacturing
GMP Audit Checklist for Cosmetics

Buildings And Facilities

Equipment

Personnel

Raw Materials

4. Are materials 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, particularly materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods?

Photo Comment

Production

3. Are samples 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?

Photo Comment

Laboratory Controls

1. Are raw materials, in-process samples, and finished products 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?

Photo Comment

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

Photo Comment

Records

Labeling

1. On the principal display panel, in addition to the name of the product, statements of identity, and net contents, does the product include the statement "Warning--The safety of this product has not been determined" if the safety of the respective product has not adequately been substantiated? Is there documentation of toxicological and/or other testing conducted by the firm to substantiate the safety of its products?

Photo Comment

7. On the information panel, does the product include in the case of a hair dye product, the caution statement of Sec. 601(a) of the Act and appropriate directions for preliminary patch testing, if applicable? (This warning applies to coal-tar hair dyes which, if so labeled, are then exempted from the adulteration provision of the Act.

Photo Comment

Complaints

Other

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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GMP Audit Checklist for Cosmetics

Use the GMP Audit Checklist for Cosmetics to ensure adherence to GMP standards through inspections of buildings, facilities, equipment, personnel, etc.

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

2. Are floors, walls, and ceilings constructed of smooth, easily cleanable surfaces and kept clean and in good repair?

3. Are fixtures, ducts, and pipes 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?

4. Is the lighting and ventilation sufficient for the intended operation and comfort of personnel?

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

1. Are equipment and utensils used in processing, holding, transferring, and filling of appropriate design, material, and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt, or sanitizing agents?

2. Are utensils, transfer piping, and cosmetic contact surfaces of equipment well-maintained, clean, and sanitized at appropriate intervals?

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

1. Do personnel supervising or performing the manufacture or control of cosmetics have the education, training, and/or experience to perform the assigned functions?

2. Do persons coming into direct contact with cosmetic materials, finished products in bulk, or cosmetic contact surfaces wear appropriate outer garments, gloves, hair restraints, etc., and maintain adequate personal cleanliness?

3. Is consumption of food or drink, or use of tobacco restricted to appropriately designated areas?

1. Are raw materials and primary packaging materials stored and handled in a manner that prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight, or moisture?

2. Are containers of materials closed, and are bagged or boxed materials stored off the floor?

3. Are containers of materials labeled with respect to identity, lot identification, and control status?

5. Are materials not meeting acceptance specifications properly identified and controlled to prevent their use in cosmetics?

1. Is the equipment for processing, transfer, and filling of utensils, and the containers for holding raw and bulk materials clean, in good repair, and in sanitary condition?

2. Are only approved materials used?

3. Are samples 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?

4. Is weighing and measuring of raw materials checked by a second person, and containers holding the materials properly identified?

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

6. Are labels examined for identity before labeling operations to avoid mix-ups?

7. Is the equipment for processing, holding, transferring, and filling of batch labeled regarding identity, batch identification, and control status?

8. Are packages of finished products bearing permanent code marks?

9. Are returned cosmetics examined for deterioration or contamination?

1. Are raw materials, in-process samples, and finished products 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?

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

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

4. Are fresh as well as retained samples of finished products tested for adequacy of preservation against microbial contamination which may occur under reasonably foreseeable conditions of storage and consumer use?

1. Are records maintained for raw materials and primary packaging materials, documenting the disposition of rejected materials?

2. Are records maintained for manufacturing of batches, documenting the kinds, lots, and quantities of materials used?

3. Are records maintained for manufacturing of batches, documenting processing, handling, transferring, holding, and filling?

4. Are records maintained for manufacturing of batches, documenting sampling, controlling, adjusting, and reworking?

5. Are records maintained for manufacturing of batches, documenting code marks of batches and finished products?

6. Are records maintained for finished products, documenting sampling, individual laboratory controls, test results, and control status?

7. Are records maintained for distribution, documenting initial interstate shipment, code marks, and consignees?

2. On the information panel, does the product include the name and address of the firm manufacturing the product or introducing it into interstate commerce?

3. On the information panel, does the product include the list of ingredients (only on the outer container) intended for sale or customarily sold to consumers for consumption at home?

4. On the information panel, does the product include the warning statement(s) required at 21 CFR 740.11, 740.12, and 740.17?

5. On the information panel, does the product include any other warning statement necessary or appropriate to prevent a health hazard? Is there documentation of the health hazard or the basis for the warning statement?

6. On the information panel, does the product include any direction for the safe use of the product?

1. Are records maintained for each reported injury, detailing the kind and the body part involved?

2. Are records maintained for each product associated with reported injuries, including the manufacturer and code number?

3. Are records maintained for medical treatments involved in reported injuries, including the name of the attending physician, if any?

4. Are records maintained for 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?

1. Is the establishment participating in the program of voluntary registration of the cosmetic manufacturing establishments (21 CFR 710)?

2. Is the establishment participating in the program of voluntary registration of cosmetic product ingredient and cosmetic raw material composition statements (21 CFR 720)?

3. Is the establishment ensuring the use of color additives that are not listed for use in cosmetics (21 CFR 73, 74, and 82) or not certified (21 CFR 80) when applicable?

4. Is the establishment ensuring the avoidance of prohibited cosmetic ingredients (21 CFR 700)?