JSC Farmak pharmaceutical company (Kyiv) has launched the project “Electronic dossier of a series of medicinal products,” upon completion of which paper-based records of information on the production of a series of medicines will be completely replaced by electronic ones. According to the company’s press release, the project partner was Siemens, which introduced similar systems for the pharmaceutical companies Bayer, Johnson & Johnson, Takeda, etc.
The electronic dossier of a drug batch includes all the necessary protocols: from quality control of raw materials to information on all stages and parameters recorded during the manufacture of the drug.
The company clarifies that the introduction of an electronic dossier minimizes the risk of operator error, optimizes the technological process and allows real-time monitoring of the situation at the site, and also provides complete statistics for calculating the overall efficiency of the equipment
In addition, the electronic dossier allows an authorized person to analyze online all indicators of the drug for deviations and release a batch of the drug remotely, from anywhere in the world.
“Digitalization is a requirement of our time. As every citizen of Ukraine has an electronic passport, so each series of drugs should have its own electronic dossier. We are interested in the deep processes of digitalization, so we introduce electronic quality certificates, electronic research protocols, electronic dossiers of drug series and much more,” Executive Director of JSC Farmak Volodymyr Kostiuk said.
Farmak is the leader of the Ukrainian pharmaceutical market, produces medicines in all 14 therapeutic groups. Among the main directions are endocrinological, gastroenterological, cardiological, neurological, anti-cold and other drugs. Annually it introduces to the market about 20 new complex component modern drugs. Currently, the company’s product portfolio includes about 400 drugs.