GMPs

Good Manufacturing Practices Have been defined differently in different countries, harmonization of regulations ongoing through ICH.

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.