International standard GMP

Standard GMP

The international standard GMP is considered one of the main in the world, defining the requirements for the production of food, medicines, dietary supplements.

The full name of this set of requirements is Good Manufacturing Practice for Medicinal Products, which in translation means “Rules for the production of medical products”.

The international standard GMP has the following objectives: to ensure a high level of product quality. Ensure that the formula of the produced product corresponds to the claimed; the product does not contain foreign impurities; there is a corresponding marking; the product is properly packaged; It will not lose its properties over the expiration date.

The beginning of the standard was laid in the USA in 1963, when the first rules of safe and high-quality manufacturing of medicines were born. The standard form of the official document, however, they took only in 1968. A year later, the World Health Organization (WHO) recommended that all countries apply the international standard GMP. Subsequently, these rules were repeatedly supplemented and adjusted until the current species was adopted.

Interest in the international standard began to appear only since 1991, when the processes of import and export of products were being intensified. However, at first, it was not possible to achieve harmony of such different rules. Only in recent years there have been some real progress.

The main elements of the GMP standard The GMP (Good Manufacturing Practice) standard provides many indicators that manufacturers must meet. For producers of certain types of products, the requirements for each stage of manufacturing are detailed: from the concentration of bacteria contained in one cubic meter of air to the marking of products. An example is the requirement for an enterprise manufacturing medicines in tablets. In such cases, GMP (international standard) requires from the organization “especially clean shops”, in which the increased sterility of the process is achieved by the entry gateways for the personnel, a special mode of air filtration and so on. What conditions are needed to move to the standard? To transfer enterprises to the international standard GMP, both external and internal conditions are necessary. At the state level, it is required: to create a legal, regulatory and methodological framework through which to monitor compliance with these rules. Here you need a staff of qualified inspectors who will have detailed methodological materials on checking companies before issuing certificates, as well as laws on prosecution of offenders.This is especially true in the category of “quality”, as the current specialists in control and issuing permits do not have sufficient qualifications. In addition, in the implementation network there is no emphasis on the quality of the finished product. Trade continues to focus more on the price of the product, often at the expense of its quality.