FDA GMP Cosmetics Audit Checklist

This digital GMP Cosmetics Checklist has been built using the SafetyCulture 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 SafetyCulture 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.

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Free FDA GMP Cosmetics Audit Checklist Checklist

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Client / Site

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.

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.

Personnel

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

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.

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.

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.

Records

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

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

Complaints

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

Other

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

Completion

• Full Name and Signature Sign

FDA GMP Cosmetics Audit Checklist

This digital GMP Cosmetics Checklist has been built using the SafetyCulture 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 SafetyCulture 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.

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. You should independently determine whether the template is suitable for your circumstances.