Quality standards

Compliance with international GMP standards at every stage of the development, production and storage of medicines guarantees the effectiveness and safety of products manufactured by Akrikhin.

Throughout a long period of time, Akrikhin has been building its own quality system, which distinguished it from many other Russian companies. In 1999, Akrikhin became the first plant in Russia that received the GMP certificate from the competent body of the government of Germany for commercial production of cardiovascular drugs in collaboration with Bristol-Myers Squibb.

In 2003, following the inspection by the World Health Organisation (WHO) under the programme of anti-tuberculosis drugs, Akrikhin received a certificate of conformity of its quality system to the GMP requirements of WHO.

Akrikhin undergoes regular quality audits by its foreign partners in contract and licensed manufacturing, as well as by Russian and foreign certification agencies and regulatory bodies.

By now, the company’s quality system has successfully passed more than 50 Russian and international audits.

In 2015, Akrikhin received a GMP certificate of the Ministry of Industry and Trade of the Russian Federation, and then confirmed its successfully in 2018.

Audits conducted by foreign partners enable implementation of modern GMP practices and international experience and, therefore, improvement of the quality of manufactured drugs. Positive audit results along with adherence to the GMP international standards and a high level of professionalism of its employees make Akrikhin an attractive partner for organising contract manufacturing for such famous foreign pharmaceutical corporations as Merck Sharp and Dohme (MSD), Johnson&Johnson, and others.

Within the frames of the investment programme for development and upgrading, in 2015 Akrikhin finished bringing its manufacturing complex in line with the requirements of GMP quality standards.

In 2019, Olga Maklakova, Quality Director at Akrikhin, was announced the best specialist in her area of expertise at IV All-Russian GMP Conference.

The quality of manufactured drugs is controlled by the Quality Control Centre. Every year, this division averagely tests over 1,600 series of raw materials, 3,000 series of packaging materials, and manufactures about 4,000 series of finished products with the issuance of quality datasheets and assignment of a respective status in the operating ERP system.

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