International Standard GMP: 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 Good Manufacturing 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 suitably packaged;
• It will not lose its properties over the expiration date.

History of occurrence

The standard was set 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 form was adopted.

Frankly ignored the standard at the initial stage of its implementation, only the Soviet Union, the Ministry of Health of which has developed its norms, in severity sometimes 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 from the 90's there were some real progress.

Russian Standard

The regulatory framework in the territory of the CIS countries began to be developed after the collapse of the USSR. The main goal was to make the two standards as close to the standards as possible, gradually approaching the rules that were defined by GMP (international quality standard).

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

It was developed by an organization called the Association of Micropollution Control Engineers (ASINKOM). Domestic rules were approved on 10.04.2004 by Gosstandart of the Russian Federation, as a result of which GOST R 52249-2004 "Rules for the production and quality control of medicines" appeared. It was put into operation on 01.01.2005, and it was believed that this standard is as close as possible to the international one. However, from 01.01.2010 the national Russian standard GMP started working. He took as a basis the European rules, and the former GOST was no longer relevant.

Where in Russia are the enterprises applying the standard

The overwhelming majority of enterprises that received quality certificates that comply with international rules are still located in Moscow, St. Petersburg and other large industrial and scientific centers of the country.

A full transfer to GMP (international standard) is planned for 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

The GMP (Good Manufacturing Practice) standard provides for a set of indicators that manufacturers must match. 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 marking of products.

An example is the requirement for an enterprise manufacturing medicines in tablets. In such cases, GMP (international standard) requires the organization of "especially clean shops", in which the increased sterility of the process is achieved by the gateways for personnel, special air filtration regime, etc. In Russia only silicon crystals and special microcircuits were manufactured in such shops.

What conditions are needed to move to the standard?

To translate Russian enterprises into the international standard GMP, both external and internal conditions are necessary. At the state level, it is required:

• Create a legal, regulatory and methodological framework, through which you can organize monitoring of compliance with these 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 prosecution of offenders.
• Form a system of registration of medicines that 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 at the enterprise level must include the following items:

• Modern equipment and facilities with 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 laboratory technicians, who control the quality of the final products.
• Optimum organization of labor.
• Revision of all technological documentation and bringing it in line with the requirements of the standard.
• An adequate rate of profit, allowing to ensure the development of production and production of new types of medicines.

Is there a standard for drug consumption in 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 will then receive highly effective and clean medicines, which will make it less painful 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 of these factors in Russia constantly come into conflict and hamper 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.