Hemofarm, being a part of ONE Stada, manufactures medicines for the entire world, and in the peak pandemic year, Hemofarm manufactured a record 6.5 billion tablets. The top quality of products in Hemofarm is imperative and therefore special attention is paid to quality control.
Hemofarm, as a leader in the pharmaceutical market and one of the largest exporters in Serbia, continues to grow thanks to regular investments, constant innovations in production and continuous investment in people and processes. In the peak pandemic year, Hemofarm produced a record 6.5 billion tablets and other forms and also 17 new brands were launched. As part of ONE Stada, Hemofarm announced planned investments of 40 million euros in plants, state-of-the-art equipment and implementation of the highest world standards in pharmaceutical industry in the year of the pandemic.
Everything done at Hemofarm is aimed at achieving top quality products. Quality control is a broad area and covers not only quality but also safety and efficacy of the drug.
- Quality Control includes microbiological control of the facility where drugs are manufactured and equipment is checked for cleanliness, then visual inspection, identification, physico-chemical and microbiological analysis of all materials that are part of the composition and packaging, physico-chemical and microbiological daily analysis of water that is used in the production plant, analysis of process parameters during drug manufacturing - explains Tamara Živković, Master of Pharmacy, Quality Control Manager at Hemofarm.
One of the starting points, for the medicine to be of good quality, is a detailed quality control of raw material for manufacturing of the medicine.
- I must emphasize that each container that arrives is identified, and there can be over a hundred of them for only one batch of starting material. It is followed by sampling and at the same time all necessary measures are applied to prevent contamination of the material that could jeopardize its further use in manufacturing. In short, the analysis of raw materials is very complex, diverse and includes a wide range of easy to perform, eye-catching identification reactions ranging from changing color of the solution to analysis using sophisticated, combined techniques that can detect traces of impurities in nanograms - explains our interlocutor.
When a medicine is manufactured, numerous and strictly defined quality control activities follow the entire process of drug manufacturing, but control and monitoring of the medicine continues even after manufacturing is completed.
- After manufacturing of a medicine is completed, the control of the ‘behavior’ of the medicine is performed through stability studies within shelf life of the medicine. One of the analyses performed is assay of active substance and its release from the medicine, analysis of degradation products, checking the appearance, everything at precisely defined time points, after 6, 12, 18, 24 months after medicine manufacturing, and even after 60 months if shelf life of the medicine is 5 years. This checks and also confirms that the medicine retains the required quality during its shelf life - says pharmacist Tamara Živković, a specialist in testing and controlling of medicines.
Pharmacists, chemists, physicochemists, biologists, microbiologists, technologists make up the quality control team at Hemofarm.
- Our tasks are different every day and in addition to practical skills, work experience and theoretical knowledge require a high level of organizational skills of each individual. The specificity of Hemofarm's Quality Control team is the openness to constant changes that are required of us by various official guidelines and regulatory requirements, and whose goal is greater agility in the response of the pharmaceutical industry to all challenges posed by market changes - emphasizes our interlocutor.
And finally, what is it like to work during the Covid pandemic?
- The work of quality control experts is related to the laboratory, which requires eight hours of wearing a mask and adequate protective equipment such as white coats, gloves, goggles, but also coverallas for colleagues who perform sterility analysis. We strictly follow all the rules, because everything in Hemofarm is subject to safety and achieving the top quality products – says Tamara Živković from Hemofarm.
