Quality standards. Quality assurance

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.

AKRIKHIN was one of the first Russian companies, to have been certified (in1999) in accordance with the GMP European Union standards for the industrial production of cardio medicines in cooperation with Bristol-Myers Squibb.

In 2003, following an inspection by the World Health Organization of the AKRIKHIN tuberculosis program, the company’s quality assurance system was recognized as fully complying with the WHO’s GMP requirements.

AKRIKHIN regularly undergoes quality audits by the company’s international contract and licensed manufacturing partners, Russian and global certification regulators.

In 2000 – 2016, AKRIKHIN passed more than 30 audits of its quality assurance system.

In 2015, AKRIKHIN obtained GMP certification from the Ministry of Industry and Commerce of Russia.

The audits by our international partners allow us to implement the latest GMP and international best practices, thereby driving a raise of product quality. Positive audit results, compliance with international GMP standards and the professionalism of our staff make AKRIKHIN a good partner for contract manufacturing for well-known international pharmaceutical companies including Merck Sharp and Dohme, Bristol-Myers Squibb and Johnson & Johnson.

As part of our investment program for development and modernization, in 2015 AKRIKHIN completed the process of bringing the whole manufacturing complex into compliance with GMP quality standards.

The Quality Control Center controls the quality of products. On average, the center tests more than 1,600 series of raw material and 3,000 series of packaging materials per year. Some 4,500 series of finished product are produced annually with quality certificates and the corresponding status in the operating ERP system.