The international GMP standard is considered one of the main ones in the world, defining the requirements for the production of medicines, dietary supplements and even food.
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 GMP standard has the following objectives:
- Ensure a high level of product quality.
- Ensure that:
- the formula of the manufactured medical product corresponds to the declared one;
- the preparation does not contain foreign impurities;
- there is a corresponding marking;
- drug appropriately packaged;
- it will not lose its properties during the expiration date.
History of occurrence
The beginning of the standard was laid in the USA in 1963, when the first rules for the safe and high-quality manufacture of medicines were born. However, they adopted the standard form of an official document only in 1968. A year later, the World OrganizationHe alth (WHO) recommended that all countries apply the international GMP standard. Subsequently, these rules were repeatedly supplemented and adjusted until they took their current form.
Only the Soviet Union frankly ignored the standard at the initial stage of its implementation, the Ministry of He alth of which developed its own standards, sometimes exceeding GMP in severity. Interest in the international standard began to appear only in 1991, when the processes for importing and exporting medicines began. However, at first it was not possible to achieve harmony of such different rules. Only since the 1990s has there been any real progress.
Russian standard
The regulatory framework in the CIS countries began to be developed after the collapse of the USSR. The main goal was to bring the two standards as close as possible on the basis of the previous standards, gradually approaching the rules that were determined by GMP (international quality standard).
The process was long. Only in 2001, a close international standard appeared in the Russian Federation. It provides that from 2000-01-07, all established and reconstructed enterprises for the production of medicines will receive licenses for the production, storage and sale of products only if they comply with the Russian analogue of GMP.
It was developed by an organization called the Association of Engineers for Micropollution Control (ASINCOM). Domestic rules were approved on April 10, 2004 by the State Standard of the Russian Federation, as a result of which GOST R appeared52249-2004 "Rules for the production and quality control of medicines". It was put into effect on January 1, 2005, and it was believed that this standard was as close as possible to the international one. However, from 01.01.2010 the national Russian GMP standard began to work. He took European rules as a basis, and the former GOST has lost its relevance.
Where in Russia are the enterprises applying the standard
The vast majority of enterprises that have received quality certificates that comply with international rules are still located in Moscow, St. Petersburg and other major industrial and scientific centers of the country.
Planned full transfer to GMP (international standard) of all enterprises. Moreover, it was supposed to end back in 2014, but many difficulties arose. It turned out that not every domestic pharmaceutical company is able to obtain the appropriate quality certificate. The main problem is that there are no personnel with sufficient theoretical and, most importantly, practical training in implementing the standard on Russian territory.
Main elements of the GMP standard
The GMP (Good Manufacturing Practice) standard provides for many indicators that manufacturers must comply with. Moreover, for pharmacists, the requirements for each stage of production are regulated in detail - from the concentration of bacteria contained in one cubic meter of air to product labeling.
An example would be a requirement for an enterprisemanufacturer of medicines in tablets. In such cases, GMP (international standard) requires the organization of "especially clean shops", in which increased sterility of the process is achieved by entrance locks for personnel, a special air filtration mode, etc. In Russia, only silicon crystals and special microcircuits were made in such shops.
What conditions are needed to switch to the standard?
In order to transfer Russian enterprises to the international GMP standard, both external and internal conditions are needed. State level required:
- Create a legal, regulatory and methodological framework with which to organize control over compliance with these rules. Here, qualified inspectors are needed who will have detailed methodological materials for checking enterprises before issuing certificates, as well as laws on bringing violators to justice.
- To form a drug registration system that would meet modern requirements. This is especially true in the “quality” category, since the current control and permitting specialists do not have sufficient qualifications. Moreover, in the sales network there is no emphasis on the quality of finished products. Trade still focuses more on the price of medicines, sometimes to the detriment of their effectiveness.
To comply with the GMP standard, GMP rules at the facility level must include the following items:
- Modern equipment andpremises with infrastructure that meets the requirements of the standard.
- Sources of raw materials with which you can achieve the desired quality of medicines.
- Skilled production specialists, as well as high-class laboratory assistants who control the quality of the final product.
- Optimal work organization.
- Revision of all technological documentation and bringing it into line with the requirements of the standard.
- Sufficient rate of return to ensure the development of production and the release of new types of medicines.
Do I need a standard for the consumption of drugs within the Russian Federation?
When answering the question of whether GMP (international standard) is needed in Russia, two aspects are usually considered.
1. On the one hand, compliance with its strictest rules makes it possible to raise the bar for the quality of medicines to a very high level. The population of Russia will then receive highly effective and pure medicines, which will make it possible to get sick less and recover faster.
2. On the other hand, domestic enterprises financially simply do not "pull" the transformation. If the enterprise manages to be transferred to a modern track, then the cost of medicines increases significantly, and their implementation becomes more complicated.
Both of these factors in Russia are constantly in conflict and hinder the implementation of the standard. However, in connection with the new geopolitical realities and the need for import substitution of medicines, the process should soonspeed up.
