GMP is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products, and medical devices. Since sampling product statistically only ensures that the samples themselves are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself.
GMP gives importance to the documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested is not correct and in order, then the product does not meet the required specification and is considered contaminated.
GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational
