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FDA and GMP Compliance
The Food and Drug Administration (FDA) is an US agency within the Department of Health and Human Services, which is also known as the largest administration for food and drug in the world. FDA is responsible for the country’s public health by assuring the safety and efficacy of human and veterinary drugs, biological products, medical devices, cosmetic and products that emit radiation. It also regulates the manufacturing, marketing and distribution of tobacco products, and is responsible for giving accurate and science-based information on medicines and food to the public so as to enhance their health.
What is GMP?
Good Manufacturing Practice or GMP is a regulation first promulgated by the US FDA in 1963, and is later adopted and customized by many other countries according to the standard issued by the World Health Organization (WHO) in 1969. GMP regulation assures proper design and control of the production process and the whole production facility. Adhered to the GMP regulation means the manufacturer has put in place stringent quality management system, appropriate and safe raw materials are being used and testing laboratories are reliable. It can ensure the products meet certain standards and are safe to consume or use, and can help eliminate or minimize the risks of contamination, mix-up or mislabeling during production. As such, GMP also represents a quality assurance system for the pharmaceutical, cosmetic and nutritional product industry.
In fact, GMP is sometimes referred to as “cGMP”, where “c” stands for “current”. That means GMP requirements are subject to changes from time to time along with technology advancement. It reminds manufacturers that they should always use up-to-date technologies and system in order to comply with the current stringent standards.
Our manufacturer
Our manufacturer CSB Nutrition is a food establishment duly registered with the State of Utah, US. It has been granted a Certificate of Manufacturing and GMP Compliance from the Utah Department of Agriculture and Food. That means products of our manufacturer are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.