While GMP for pharmaceuticals states the efficacy and safety of drugs, GMP for cosmetics requires only safety. The purpose of GMP for cosmetics is to ensure the safety of cosmetics by ensuring the same quality in processing, manufacturing, packaging, and storage as in the manufacture of pharmaceuticals.
In the U.S., for example, if a sun protection factor (SPF) claim is made for a sunscreen cream or lotion, it is treated like an OTC (over-the-counter drug) and is subject to the same FDA inspections as a drug. Although a different approach is required than for pharmaceuticals and medical devices, the same requirements apply: sufficient accountability is required during inspections.
Each company is responsible for assuring the safe quality of its products. This need is related to the various regulations governing the sale of cosmetics. For example, in the United States, the Federal Food, Drug, and Cosmetic Act (Section 301), enacted by the FDA, prohibits the sale of “counterfeit” or “misbranded” cosmetic products. In Canada, the Food and Drugs Act (Articles 16 and 18) requires that cosmetics for sale must be manufactured and stored in a clean and sanitary environment.
In some countries, GMP for cosmetics is supported and strongly recommended by national authorities, but is not mandatory. In the United States, GMP is required of cosmetic businesses but is listed as a guideline. Similarly, in Canada, cosmetic businesses are encouraged by Health Canada to follow GMPs as defined in the ISO 22716 standard.
In other regions, however, GMP is a legal requirement for cosmetics manufacturers. In Europe, for example, the Cosmetics Regulation (EC) 1223/2009 requires cosmetics intended for sale on the EU market to comply with the cosmetics GMP guidelines outlined in ISO 22716.
Our engineering consultants, CM Plus, are well versed in these regulations and have extensive experience in facility design, validation, and QMS to assist you in the creation and operation of your facility. CCI is able to provide information of great importance to the cosmetics industry in ASEAN countries, especially in Indonesia. We have successfully completed several international scale factories in Indonesia.