Good Manufacturing Practices (GMPs) for Cosmetic Products
Section 16 of the Food and Drugs Act prohibits the sale of cosmetics that are manufactured, prepared, preserved, packaged or stored under unsanitary conditions, that may cause injury to the health of the user, or that consist of any filthy or decomposed substance or any foreign matter. Section 18 of the Act prohibits the acts of manufacturing, preparing, preserving, packaging and storing a cosmetic under unsanitary conditions with the intention of sale. Under the Act, "unsanitary" means: "such conditions or circumstances as might contaminate with dirt or filth, or render injurious to health, a food, drug or cosmetic."
In order to meet these safety and quality requirements, Health Canada encourages all cosmetic manufacturers to adhere to Good Manufacturing Practices (GMPs). Health Canada, along with its partners in the International Cooperation on Cosmetic Regulation (United States, European Union and Japan), endorse the use of the International Standards Organization (ISO) Guidelines on Good Manufacturing Practices for Cosmetics, ISO Standard 22716.
GMPs are manufacturing guidelines which are used to ensure product quality control and an effective approach to risk management. These guidelines set out standards for product manufacturing, testing, storage, handling and distribution, to ensure that each step of manufacturing is acceptable for quality and safety of the product.
GMPs do not provide specifics on how products are to be manufactured. Instead they outline the expected outcome of the processes. Each manufacturer, large or small, may have a unique means of achieving these outcomes.
Some Issues to Consider for GMPs
Below are some important considerations when manufacturing cosmetics to ensure they remain free of contamination. This list is far from exhaustive. More detailed approaches can be found under the "Sources of Information" section that follows.
Building and Facilities
- building is adequate for the manufacture and storage of cosmetics
- walls, floors, fixtures, ducts, pipes, lighting, ventilation, water supply, drainage, toilet facilities are adequate for the work and in good repair
- building has adequate air supply quality
- building has adequate pest control program to prevent attracting or harbouring pests
- equipment used in processing is adequate, well maintained, and free from contamination
- personnel have adequate education, training, experience and personal cleanliness
- raw materials are stored and handled to prevent contamination or alteration
- materials are tested or examined to assure quality
- manufacturing and control procedures are established and written instructions for procedures are maintained
- raw materials, samples and finished products are tested or examined to ensure they meet the defined standard
- water supply is free from contamination
- records are maintained for raw materials, manufacturing, finished products and distribution
- labels on finished product contain the required information (including lot numbers)
- establishment maintains a consumer complaint file
- products adhere to all regulatory requirements
- products do not contain prohibited ingredients or substances
Sources of Information
- The International Standards Organization (ISO):
ISO Standard 22716: Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices
- The United States Food and Drug Administration (US FDA):
The Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist
- The Personal Care Products Council (PCPC)
Quality Assurance Guidelines
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