Quality of products manufactured by AVVA RUS GMP EU

The quality system and proper manufacturing conditions at JSC "AVVA RUS" have been confirmed by state European auditors. The high quality of JSC "AVVA RUS" products is officially confirmed by certificates of compliance with European GMP* EU requirements.

JSC "AVVA RUS" produces well-known drugs such as Lactofiltrum, Filtrum, Micrasim, Ecofuril, Minolexin, as well as Ecoantibiotics — a type of antibiotic that preserves the intestinal microflora thanks to the prebiotic included in their composition. One of the priority areas for "AVVA RUS" is the preservation of human microecology.

The production site of JSC "AVVA RUS" is located in Kirov and operates in accordance with GMP and ISO 9001 standards. Currently, over 400 qualified specialists are employed at the production facility.

Since January 2014, certification of enterprises for compliance with the Russian GMP standard has become mandatory (approved by Order of the Ministry of Industry and Trade of the Russian Federation No. 916 dated June 14, 2013, as amended on December 18, 2015 "On Approval of the Rules of Good Manufacturing Practice"). It is worth noting that the standard itself sets requirements for the organization of production and quality control of medicinal products for medical use.

In the autumn of 2017, European state auditors conducted an audit of the quality system and good manufacturing practices in place at JSC "AVVA RUS". In January 2018, JSC "AVVA RUS" received the European GMP EU certificate for the production of medicinal products for medical use, thereby proving the highest standard of quality of its products. This fact once again confirms that JSC "AVVA RUS" complies with the strict European production standards adopted, in particular, in countries that are members of PIC/S* (The Pharmaceutical Inspection Co-operation Scheme - countries that have signed an intergovernmental agreement in the field of pharmaceutical inspection conducted by state authorities to improve cooperation in good manufacturing practice between regulatory authorities and the pharmaceutical industry) with its headquarters in Geneva.

Leading global pharmaceutical companies regularly confirm the compliance of their drug production with the international GMP standard. Currently, out of approximately 200 pharmaceutical productions operating in the Russian Federation according to the GMP standard, less than 10% of enterprises have a certificate of compliance with the European GMP EU standard.

In the Kirov Region, where the production enterprise of JSC "AVVA RUS" is located, there are several large pharmaceutical enterprises, among which JSC "AVVA RUS" was the first to receive the GMP EU certificate of compliance.

The GMP EU certificate reflects our values and consistent quality in everything we do.

Alexey G. Egorov, General Director of JSC "AVVA RUS", commented on this news:

"Obtaining the GMP EU certificate reflects the mission, goals, and values adopted at JSC 'AVVA RUS'. We have always strived to be leaders in creating innovative drugs to improve the safety of treatment and disease prevention. In addition to Russia, JSC 'AVVA RUS' products are supplied to CIS countries and beyond. Thanks to this event, the company is opening new horizons and will strengthen its position as a manufacturer of high-quality European-level medicines."

The international GMP (Good Manufacturing Practice) standard is a standard that includes norms and requirements necessary to ensure good manufacturing practice for pharmacological enterprises. The GMP standard rules cover all aspects related to the manufacture and quality testing of the following types of production:

• medicinal products;

• medical equipment;

• products intended for diagnostics;

• dietary supplements, vitamins, minerals, etc.;

• active ingredients.

GMP production standards include norms concerning:

• personnel, premises, and equipment;

• quality control;

• documentation;

• product analysis and testing;

• packaging and labeling;

• storage and distribution;

• methods and manufacturing process.

The European GMP standard is aimed at ensuring the high-quality and safe manufacture of medical products for humans and animals.

Link to download the certificate

Link to download the certificate

Abbr. Good Manufacturing Practice.
** Links to certificates
*** Abbr. Pharmaceutical Inspection Co-operation Scheme