GMP - Good Manufacturing Practices are in effect in 104 countries, either through national codes, adherence to
regional codes, or adoption of the WHO code. Whether they are stated to be regulations, as in Japan, Korea and the United States; or directives, as in the European Union, or Guides as in the United Kingdom, or Codes as in Australia, the intent of the authorities is the GMPs be strictly
followed to consistently assure pharmaceutical product quality.

A Good Manufacturing Practice(GMP) is a set of regulations, civil codes,and guidelines for the manufacture of drug substances (also known as active pharmaceutica ingredients (APIs)) and drug products (known as medicinal products in Europe), medical devices in vivo and in vitro diagnostic products, and foods. In the GMPs are referred to as 'cGMPs' or 'current Good Manufacturing Practices'. GMP is a term that is recognised worldwide for the control and management of Manufacturing and quality control testing of pharmaceutical products.

sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is 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 (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated adulterateded in the US). Additionally, GMP requires that all manufacturing and testing equipment have been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported