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GMP Guildelines on Inspection of Suppliers

The Federal Food, Drug and Cosmetic Act protects the consumer from cosmetics that have been altered or misbranded. Good Manufacturing Practice (GMP) Guidelines within this law include inspection of suppliers to ensure safe cosmetics. The law states that a cosmetic is altered if it contains a harmful substance, filth, noncertified color additive or is manufactured under unsanitary conditions. The law states that a cosmetic is misbranded if it has labeling that is false, inconspicuous or misleading.

  1. Building and Equipment

    • The guidelines for inspecting establishments are that the building should be the correct design for storage of materials and sanitation. Cleanliness is very important. The ventilation must be adequate. Lighting should be comfortable for personnel. The sewage system including washing and toilet area must be sanitary to ensure employees' personal cleanliness. The equipment must be designed to prevent buildup of foreign material that will alter the cosmetic. The equipment must be sanitized regularly and stored properly to maintain cleanliness.

    Raw Materials and Production

    • The guidelines for inspecting raw materials are that they must be handled properly to prevent contamination with chemicals or microorganisms. They should not be exposed to excessive cold, sunlight, heat or moisture. Containers should be properly labeled, stored and free of filth. The proper production of cosmetics should have well-established written instructions and use only approved materials. Samples will be taken to ensure the product is free of hazardous materials. A second person should double check to ensure the product is properly prepared and labeled.

    Personnel

    • The guidelines state that the cosmetic supplier personnel should be properly trained and supervised to ensure they adequately prepare and handle the supplies/finished product. They should wear lab coats, gloves and hair restraints to protect against alteration of the finished product. Personnel should have adequate personal cleanliness to maintain clean supplies. They should not drink, eat or smoke in the production area to maintain cleanliness.

    Labeling and Recordkeeping

    • The guidelines for labeling, to ensure that the cosmetic has not been misbranded, are that all equipment and materials are properly labeled and have a batch identifier. Finished products must have permanent barcodes that identify the name of the product and net contents. Records of raw materials, finished products and documents of rejected material should be maintained.

    Laboratory Controls and Complaints

    • The guidelines for laboratory controls are that all raw materials and finished products must be inspected to identify their compliance with GMP. The water supply should be tested regularly for safety. A record must be kept of complaints against the product, which includes the severity and treatment of the complaint.

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