government or industry set standards for the production of safe, efficacious, and high-quality ingredients and products. [CUB
Federal regulations that specify the legal requirements for the sanitary conditions under which food can be processed.
Regulatory requirements in the U.S. defined by the FDA (CFR 21 Part 110) and, for meat and poultry products, by the USDA (CFR 9 Parts 308/381.45). Essentially the GMP regulations describe universal steps or procedures that control the operational conditions within a food establishment allowing for environmental conditions that are favorable to the production of safe food.
Regulations that describe the methods, equipment, facilities, and controls required for producing products that are safe, pure, and effective.
Good Manufacturing Practices are standard guidelines set out by the FDA to ensure drug development is carried out in safe and quality processes, to avoid contamination and ensure repeatability.
Good Manufacturing Practices (GMP) relate to quality assurance programs that a manufacturer would establish to ensure that its products are consistently produced to the safety and quality standards appropriate to their intended use. They are conditions specific to the product being manufactured. In the case of bottled water, the Canadian Food Inspection System Implementation Group has developed a code of hygienic practice (Code of Hygienic Practice for Commercial Prepackaged and Non-Prepackaged Water) which provides guidance on what could be considered GMP for bottlers of water. The document is available at: http://www.cfis.agr.ca/english/regcode/bw/bwcode_e.shtml
Health Canada's regulatory framework of requirements for the manufacture or sale of safe, wholesome food products. Based in part on the Codex Alimentarius Code of Practice, General Principles of Food Hygiene, the GMPs are HACCP based and were designed to enhance the safety of all food, both domestic and imported offered for sale in Canada.
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Standards published in the Code of Federal Regulations and used by the Food and Drug Administration to ensure the quality of marketed products and that products are produced under sanitary conditions. Any FDA-regulated product can be designated adulterated if the manufacturing methods or facilities for processing do not conform with GMPs. GMPs are developed through a consultative process between the FDA and the affected industry.
Procedures for manufacturing dietary supplements that are used to ensure a consistent level of quality. GMPs embody procedures that ensure purity, cleanliness, freshness, and proper labeling.
Measures to ensure an overall effective approach to product quality control and risk management. They apply to places, people, processes and products with respect to which activities are being conducted. Please refer to Part 3 of the Natural Health Products Regulations and the Good Manufacturing Practices Guidance Document.