International GMP standard: characteristics and applications

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

What is the standard for?

The full name of this set of requirements is GoodManufacturing Practice for Medicinal Products, which means "Rules for the production of medical products". The international standard GMP has the following objectives:

1. Ensure a high level of product quality.
2. Ensure that:

• the formula of the produced medical product corresponds to the claimed;
• the preparation contains no foreign impurities;
• there is a corresponding marking;
• the preparation is appropriately packaged;
• It will not lose its properties over the expiration date.

History of occurrence

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.

Frankly ignored the standard on the initialthe stage of its implementation is only the Soviet Union, the Ministry of Health of which has developed its norms, sometimes severely exceeding GMP. Interest in the international standard began to appear only in 1991, when the processes of import and export of medicines began. However, at first, it was not possible to achieve harmony of such different rules. Only with the 90's there were some real progress.

Russian Standard

Normative base on the territory of the CIS countriesDeveloped after the collapse of the USSR. The main goal was to make the two standards as close as possible on the basis of the previous standards, gradually approaching the rules defined by the GMP (international quality standard).

The process was long. Only in 2001 in Russia appeared a close international standard. It stipulates that from 01.07.2000 all enterprises that are created and reconstructed to produce medicines will receive licenses for production, storage and sale of products only if they comply with the Russian GMP analogue.

It was developed by the organization ofThe Association of Micropollution Control Engineers (ASINCOM). Domestic rules were approved on 10.04.2004 by Gosstandart of the Russian Federation, as a result of which GOST R 52249-2004 "Rules of production and quality control of medicines" appeared. It was put into operation on 01.01.2005, and it was believed that this standard is the closest to the international one. However, from 01.01.2010 the national Russian standard GMP began to operate. He took as a basis the European rules, and the previous GOST has lost its relevance.

Where in Russia are the enterprises applying the standard

The vast majority of enterprises thatreceived certificates of quality, consistent with international rules, while located in Moscow, St. Petersburg and other major industrial and scientific centers of the country.

A full transfer to GMP (internationalstandard) of all enterprises. Moreover, it was supposed to end back in 2014, but many difficulties arose. It turned out that not every domestic enterprise in the pharmaceutical industry is able to obtain an appropriate quality certificate. The main problem is that there are no personnel who have sufficient theoretical and, what is especially important, practical training in implementing the standard on Russian territory.

The main elements of the GMP standard

GMP (Good Manufacturing Practice)provides a set of indicators that manufacturers must meet. And for pharmacists, the requirements for each stage of manufacturing are regulated in detail - from the concentration of bacteria contained in one cubic meter of air to the labeling of products.

As an example,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 gateways for personnel, a special mode of air filtration, etc. In Russia only silicon crystals and special microcircuits were manufactured in such shops.

What conditions are needed to move to the standard?

In order to transfer Russian enterprises to the international GMP standard, both external and internal conditions are needed. At the state level, it is required:

• Create a legal, normative and methodicalThe bases with which help it is possible to organize the control over observance of the given rules. Here, qualified inspectors are needed, who will have detailed methodological materials on the inspection of enterprises before issuing certificates, as well as laws on bringing to justice violators.
• Form a system for registration of medicinal productsmeans, which would meet modern requirements. This is especially true in the category of "quality", as the current specialists in control and issuing permits do not have sufficient qualifications. Moreover, in the implementation network there is no emphasis on the quality of the finished product. As before, trade focuses more on the price of medicines, sometimes at the expense of their effectiveness.

In order for the GMP standard to be fulfilled, the GMP rules at the enterprise level should include the following items:

• Modern equipment and facilities with an infrastructure that meets the requirements of the standard.
• Sources of raw materials, with which you can achieve the desired quality of medicines.
• Qualified production specialists, as well as high-quality lab technicians who control the quality of the final products.
• Optimal organization of labor.
• Revision of all technological documentation and bringing it into compliance with the requirements of the standard.
• A sufficient rate of profit, allowing to ensure the development of production and production of new types of medicines.

Is there a standard for drug consumption within the Russian Federation?

When answering a question about whether a GMP (international standard) is needed in Russia, two aspects are usually considered.

1. On the one hand, compliance with its strictest rules allows you to raise the bar of quality of medicines to a very high level. The population of Russia then will receive highly effective and pure medicines, which will make it less sick and more likely to recover.

2. On the other hand, domestic enterprises financially simply do not "pull" the transformation. If the enterprise manages to be transferred to modern rails, the cost price of medicines essentially increases, and their realization becomes more complicated.

Both these factors in Russia are constantly entering intocontradiction and inhibit the implementation of the standard. However, in connection with the new geopolitical realities and the need for import substitution of medicines, the process should soon be accelerated. </ strong </ p>