Farmak, the Ukrainian pharmaceutical market leader, is implementing the project entitled “Electronic batch dossier of a medicinal product” which will fully replace the hard-copy information carriers on a medicinal product batch manufacturing with electronic ones. Siemens, which introduced similar systems for global pharmaceutical giants Bayer, Johnson&Johnson, Takeda and others, is the project partner.
The electronic batch dossier of a medicinal product includes all necessary records: from quality control of raw materials to information on all stages and parameters recorded during the manufacture of the medicinal product.
The introduction of an electronic dossier minimizes the risk of operator error, optimizes the technological process, makes it possible to monitor the situation on site in real time, and provides complete statistics for calculating the overall efficiency of the equipment. In addition, in case of an electronic dossier, the qualified person can analyze all parameters of a medicinal product online for deviations and release a batch of the medicinal product remotely, from any place in the world.
Also, the use of paper and other consumables is reduced manifold after the implementation of this system.
“Digitalization is a requirement of our time. Just as every citizen of Ukraine has an electronic passport, so should every batch of medicinal product have an electronic dossier. Farmak has a very high level of digitalization and we are constantly improving in order to be a leader not only in Ukraine, but also to expand the Company’s footprint globally. Farmak has a transparent electronic system for reporting, budgeting, manufacturing planning, sales, document management, as well as personnel appraisal and training. We are interested in in-depth digitalization processes, so we are introducing electronic certificates of quality, electronic study records, electronic batch dossiers of medicinal products and much more,” said Volodymyr Kostiuk, Chief Executive Officer of JSC Farmak.
