Use of GMP standards for pharmaceutical plants

What is GMP? This abbreviation stands for Good Manufacturing Practice, which literally translates as "good manufacturing practice".

These are a kind of rules applied to the order of organizing production processes, production and quality control of drugs.

The main purpose of applying these standards is to ensure the release of high-quality drugs:

• free of foreign inclusions in composition;
• corresponding to the declared formula;
• having reliable packaging and proper labeling;
• retaining properties during the declared shelf life;

These quality characteristics are achieved by complying with the specified GMP standards, which include rules and requirements for raw materials, personnel, personal hygiene, special clothing, etc. Our company FSR provides professional cleaning services in clean areas of enterprises, thereby participating in the process of creating drugs.

The GMP standard was first introduced in the USA in 1963. Already in 1969, the World Health Organization recommended it for use by all states.

Currently, there are both national rules and standards that apply only within a specific state, and there are also interstate ones that regulate the production of drugs at the level of state unions. Our international experience shows the accumulated expertise in compliance with GMP standards over the past 20 years of work.

In the Russian Federation, Federal Law No. 61-FZ of 12.04.2010 (as amended on 26.12.2024) "On the Circulation of Medicines" is in force, Article 3 of which establishes the priority of the rights of the Eurasian Economic Union over the norms of this Federal Law (in case of contradictions).

Thus, the use of GMP standards in the pharmaceutical industry maintains high standards of quality and safety of manufactured products, which FSR follows.

In the area under consideration, this issue is especially relevant, since human health ultimately depends on the quality of the products.

FSR Company thoroughly knows all the requirements and standards in terms of professional cleaning and has been working in strict accordance with them for many years.