GMP standards (Good Manufacturing Practic, Good Manufacturing Practice) - a system of rules, regulations and guidelines for the production of pharmaceuticals, medical devices, articles diagnostic purpose, food additives and active ingredients. In contrast to quality control procedures by the study of selected samples of such products, which ensures the suitability for use only within these samples, GMP standard reflects a holistic approach and regulates and evaluates the actual production parameters and laboratory testing.

GMP Certificates notes that the products listed above is manufactured in strict accordance with the required chemical composition in conditions not allowed to contact third-party materials, and properly packaged, which guarantees the preservation of all properties within the shelf life.

Information for manufacturers!

On September 1, 2010, all pharmaceutical production are required to be certified according to the law "On Circulation of Medicines", which involves the transfer of all production in the world recognized by GMP quality standards.

The procedure of transition to GMP standards should be completed in 2014, but to comply with some specific requirements imposed by law was provided the possibility of certification by 2015 -2016 years .:

The federal law from 12.04.2010 N 61-FZ (ed. Of 12.29.2015) "On Circulation of Medicines"

What are the advantages of the GMP certificate?

  • it increases the competitiveness of products
  • it stabilizes product quality
  • manufaturer receives benefits for participation in tenders and other events on a competitive basis
  • it increases the investment attractiveness of the product
  • it offers the opportunity to enter the world market
  • it increases the prestige of the company in the domestic market

The introduction of the standard in Russia

GMP standard was first developed in the US in 1963 in order to resolve drug production and create the most secure production environment. Standard edited many times until 1992. The standarts underwent numerous changes until 1992. Being developed with the participation of the World Health Organization, the standard has received international status in 1968

Russia also developed analogue of national standard by Association of Engineers to control micropollutants in 2004, which was called GOST R 52249-2004 "Rules of production and quality control of medicines" - Good manufacturing practice for medicinal products (GMP)

The main difference from the quality control procedures by conducting research of product samples, which guarantees suitability for the use only of these samples (or parties, released in the nearest time to provided production ), GMP standard certificate reflects the holistic approach, regulates and evaluates the actual parameters of manufacturing and laboratory testing.

Our experts will consult and help to obtain the GMP certificate .

If you need to certify your products, develop technical documentation or receive any service connected to certification process of:

  • pharmaceuticals
  • medical devices
  • articles diagnostic purpose
  • food additives
  • active ingredients

You can contact our specialists and they will answer all your questions: 

Address: Golovinskoye shosse 8, building 2a,
125212 Moscow, The Russian Federation  
Phone: +7 (495) 232-61-71