Olga Oleksiichuk

Quality director

Dec 11, 2018

Quality is Built in Farmak’s Policy

Farmak has always seen its activity from the perspective of quality.

Quality has become one of the drivers of Company’s success allowing it to reach leading positions in Ukraine and enter international markets with stringent regulation systems.

Quality is an integral part of Farmak’s policy. In practice, it means a wide range of forward-thinking solutions. I have always emphasized the fact that the landmark in our history was 1995, when the collective elected Filya Ivanivna Zhebrovska as the General Director. The Company’s strategy changed: we changed the path from the manufacture of APIs to the manufacture of finished medicines. In the same period a decision was made to implement international quality standards, first ISO 9000 series, later GMP. At that time, we acted proactively because the requirement of GMP compliance was established in Ukraine only in 2001 and was adopted as a recommendation. However, these rules were mandatory in Europe. At that period of time, our products were present in the western markets, so we started active work on implementation of good manufacturing practices, and, as a result, became one of the first Ukrainian pharmaceutical manufacturing sites, which implemented international quality standards in its activities.

Strategic management decisions outrunning the existing regulatory requirements underlay the Company’s growth.

An important milestone in development of the quality system was adoption of a new revision of ISO 9001. The project for implementation of quality management systems supported by the Germany Government started in 2000 and lasted for a year. Eventually, we passed national and European certification and built a foundation for other quality systems, among which are medical devices and food supplement systems, environmental management system, safety and health system and others. The same foundation underlay integration of GMP requirements, which serves as a pre-requisite for the Company’s growth.

It was one of the first international projects. In addition to knowledge and skills, it triggered powerful motivation for our team, and a lot of our employees were involved in identification of the processes, which are significant in terms of quality, and in establishment of interconnection and standardization of such processes. Our German colleagues pointed out that three components shape the success, which are “willing”, “capable” and “able”. These features are characteristic of our personnel. Our true value is the strongly enthusiastic personnel, who take on work with zest. This could never be forced by either requirement or instruction! Farmak, in its turn, always offers opportunities for the development. We established active cooperation with best European companies, which provide training and implement best pharmaceutical practices. The personnel’s strong motivation and deep knowledge of the products and processes are the key to Farmak’s success.

The personnel have the key role in the system, which is why the main quality assurance principles are incorporated in our Quality Policy and are communicated to each employee. Generally speaking, the Quality Unit is responsible for quality, and these responsibilities include regulatory compliance of all quality systems, independent control at all production stages and product certification by the Qualified Person. This Unit does not diminish the role and responsibility of other employees, but, on the contrary, is a core in the multifunctional quality chain.

Highly skilled subject-matter experts of the Quality Unit have deep understanding of the statutory requirements, convert them into the internal activities, train the personnel, monitor compliance of the products, processes and the system itself. Such information is reviewed by the top management with the aim of evaluating if the pharmaceutical quality system complies with strategic goals and objectives and identifying the processes to be improved. Such management review is performed on an ongoing basis and it’s a powerful tool to improve the performance and the system as a whole. For the personnel the system is a source of clear instructions. That being said, the Company’s efficiency is continually improved.

Despite stringent regulation of the system, it offers great opportunities for improvements. Based on profound knowledge of the product and process, by applying risk assessment tools, decisions can be made and changes can be introduced in numerous areas in a timely fashion. At the same time, the manufacturer retains its key responsibility for ensuring that all the processes are in a state of control, and the quality of the products are always high. Everyone has a possibility to offer his or her proposal for improvement, and, when it is found to be substantiated, effectively and not to affect quality, it will be considered. This is why, it’s the Quality Unit, which is responsible for final evaluation of any changes in the Company.

Farmak is committed not only to production of medicinal products, but also to development of medicines. So, the well-known principle of the pharmaceutical industry “Quality by Design in Pharmaceutical Development” is related to our activity. At the stage when the batch formula of a medicinal product is selected, the manufacturing technology is elaborated, all factors capable of influencing the variability of the product and the process are considered, and the quality control strategy is identified. Comprehensive scientific studies are carried out. Concerning solid dosage forms, bioequivalence to a reference product is also studied. It means that efficacy and safety of medicinal products in medical practice are guaranteed. After the development, quality is comprehensively maintained by Good Manufacturing Practice at each of the product lifecycle stages, including scale-up transfer, production processes and eventually sale to the customer. We are continuously broadening knowledge of our products and processes and, where appropriate, are able to implement changes to improve their quality.

Along with production development, the quality control area has also developed in the Company as the next significant GMP area. The Quality Control Department was reorganized and became the Quality Control Unit with advanced functions, with a new management structure, and with the state-of-the-art laboratory equipment. After the quality assurance concept was improved, the quality control system became more proactive. Statistical analysis of representative attributes, risk assessment, cooperation with qualified manufacturers and suppliers of raw materials and other materials, the change management system etc. brought an opportunity to implement optimization and continual improvement programs in test laboratory preserving guaranteed quality of our products. The improvements targeted the laboratory information management system (LIMS). Use of the new LIMS LabWare and automated data collection from all instruments and equipment in a single system will allow timely receipt of quality control results and will also provide product-based trend monitoring because the price of a non-conformance in our products is too high.

Newest quality control tools allow us to predict potential deviations and prevent their recurrence.

The list of products containing over 250 medicines covering a wide range of dosage forms, use of information technologies in the quality system have become an important tool supporting our Company’s regulatory compliance.

Electronic management of the key processes of the quality system in the EDMS and implementation of the LIMS in test laboratories are already giving the positive results. However, we do not rest on our laurels. The need in IT technologies to be utilized and developed in all areas of our business is increasing, which is why Farmak allocates a certain amount of money for computerization and digitization of all processes each year. Our ultimate goal is to ensure that all stages of the product lifecycle are traceable through their “electronic trace”.

IT technologies ensure efficiency, which every pharmaceutical company both in Ukraine and abroad desires to achieve.

Good manufacturing practices are mandatory. However, the ways they are implemented in production can differ. Some may find that minimum compliance with the GMP rules is enough to operate in the local market. A well-established company, which develops high-tech products, actively develops in biotechnologies, has state-of-the-art knowledge in quality and firmly integrates it into all processes, gets possibilities beyond its horizons. Today, we enter new well-regulated markets with confidence. Today’s accomplishments allow us to declare our success: due to the existing GMP certificates issued by European authorities we perceive that the regulatory pressure has decreased. For instance, the German, British and Australian regulatory authorities recognized the existing European GMP certificates without additional inspection of the manufacturing site. Presence in the US market is even more turning into reality. We have indeed a lot of work to do. Yet, we can already state that Farmak has established all necessary approaches to maintain leadership in Ukraine, to improve its position and to implement further ambitious plans.

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