The international GMP standard is considered one of the main in the world that defines 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:
- Provide a high level of product quality.
- Ensure that:
- the formula of the produced medicinal product corresponds to the declared one;
- the preparation does not contain impurities;
- there is a corresponding marking;
- the drug is suitably packaged;
- It will not lose its properties over the expiration date.
History of occurrence
The standard began in the United States in 1963, when the first rules for the safe and quality manufacture of medicines were born. However, they accepted the standard form of an official document only in 1968. And a year later, the World Health Organization (WHO) recommended that all countries apply the international GMP standard. Subsequently, these rules were repeatedly supplemented and adjusted until they took on their current form.
At the initial stage of its implementation, only the Soviet Union openly ignored the standard, the Ministry of Health of which developed its own standards, sometimes exceeding strict GMP standards. Interest in the international standard began to show itself only in 1991, when the process of import and export of drugs began. However, at first it was not possible to achieve harmony of such different rules. Only in the 90s did any real progress appear.
The regulatory framework in the CIS began to be developed after the collapse of the USSR. The main goal was - on the basis of previous standards to bring the two standards as close as possible, 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 July 1, 2000, all newly created and reconstructed drug manufacturing enterprises will receive licenses for the production, storage and sale of products only if they comply with the Russian GMP equivalent.
Its development was carried out by an organization called the Association of Microcontaminants Control Engineers (ASINCOM). Domestic rules were approved on April 10, 2004 by the State Standard 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 effect on 01.01.2005, and it was believed that this standard is as close to international as possible. 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 the Russian Federation are the enterprises applying the standard
The vast majority of enterprises that have received quality certificates that comply with international regulations are still located in Moscow, St. Petersburg and other major industrial and scientific centers of the country.
A full transfer to GMP (international standard) of all enterprises is planned. Moreover, it was supposed to end in 2014, but many difficulties arose. It turned out that not every domestic pharmaceutical industry enterprise is able to obtain an appropriate quality certificate. The main problem is that there are no cadres with sufficient theoretical and, most importantly, practical training in the implementation of the standard in the Russian territory.
Key elements of the GMP standard
The GMP standard (Good Manufacturing Practice) provides many indicators that manufacturers must meet. Moreover, for pharmacists, the requirements for each stage of manufacture are regulated in detail - from the concentration of bacteria contained in one cubic meter of air, to the labeling of products.
An example is the requirement for a pill manufacturing company. In such cases, GMP (international standard) requires the organization of "very clean shops" in which increased sterility of the process is achieved by entrance gateways for personnel, a special air filtration mode, etc. In Russia, only silicon crystals and special microcircuits were manufactured in such shops.
What conditions are needed to switch to the standard?
To transfer Russian enterprises to the international GMP standard, both external and internal conditions are needed. At the state level requires:
- Create a legal, regulatory and methodological framework with which you can organize control over compliance with these rules. Here, qualified inspectors are needed, who will have in their hands detailed methodological materials for checking enterprises before issuing certificates, as well as laws on holding violators accountable.
- Create a drug registration system that meets modern requirements. This is especially true in the category of “quality”, as current experts in control and issuing permits lack sufficient qualifications. Moreover, in the sales network there is no emphasis on the quality of finished products. As before, trade is oriented more toward the price of medicines, sometimes to the detriment of their effectiveness.
To comply with the GMP standard, GMP rules at the enterprise level should 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 manufacturing specialists, as well as high-class laboratory assistants who control the quality of the final product.
- The optimal organization of labor.
- Review of all technological documentation and bringing it in line with the requirements of the standard.
- A sufficient rate of return, which allows for the development of production and the release of new types of medicines.
Is a standard for the consumption of drugs within the Russian Federation necessary?
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 allows you to raise the bar on 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 less painful and more likely to recover.
2. On the other hand, domestic enterprises simply do not “pull” the transformation financially. If the enterprise manages to transfer to modern rails, then the cost of drugs increases significantly, and their implementation is complicated.
Both of these factors in Russia constantly come into conflict and impede the implementation of the standard. However, due to new geopolitical realities and the need for import substitution of medicines, the process should accelerate in the near future.