• K Pimonova

Ключові слова:

quality, GCP, GMP


Pharmaceutical industry is one of the key in the economy of the state, because it provides the welfare of the  society, forms the preconditions for demographic growth. Quality for pharmaceuticals is the most important factor of competitiveness. This is due to the importance of receiving high-quality medicines for the population, the opportunity to gain advantages over competitors not through marketing strategy, but because of higher effectiveness of drugs. Requirements of GxP standards include the principles of the industry's activities in various areas, namely, in clinical trials, production, inventory management, marketing activities, pharmacy practices, etc. The provision of a high level of quality in pharmaceutical companies is ensured through a series of standards that are applied at different stages of the drug's lifecycle (fig.1).Figure 1 - Concept of quality assurance of medicinal products Figure 1 - Concept of quality assurance of medicinal products Based on [1,2] Ukrainian enterprises, which performs preclinical tests on its own, must be guided by the principles pointed in Guidelines “Good Laboratory Practice” (GLP). The next stage in the development of medicines is clinical trials that are governed by the Good Clinical Practice Guide (GCP). At the stage of production, compliance with the Good Manufacturing Practice (GMP) requirements is important. The process of storage and transportation of drugs regulates by Good Storage Practice Guide (GSP). In the course of foreign economic activity, its expansion, the manufacturer must ensure that the contractor, who will deal with the distribution of drugs, performs its activities in accordance with the requirements of GDP (Good distribution practice). Pharmacy chains also need to provide high quality medications according to the GPR standard - Good Retail Practice. Due to globalization processes that have embraced the world, these standards are unified. For example, in European countries, they have the form of English abbreviation. In Ukraine, it is the Guide. One of the development directions of pharmaceutical companies is the geographical expansion of export activities. In this context it is important to pay close attention to the quality of the exported products and to understand if there is any specific pharmaceutical legislation in a particular country. Thus, the quality of finished products in the pharmaceutical industry should be formed at the beginning of the life cycle of the medicinal product. With the transition to a new stage, manufacturers should be concerned about compliance with all the requirements of legislation and quality standards, ensuring the sterility of premises and work clothes, high qualifications of staff, employee awareness of quality at the enterprise (GxP testing is obligatory to all employees in pharmaceutical companies), etc. High-quality medicinal product is the result of many years of development, improvement. Taking into account all the activities of the enterprise and all the processes involved in the receipt of the drug to the consumer, quality management is a key factor of the success of the company strategy.

Thesis Supervisor: Chornii V.V., PhD of economic sciences






Міжнародний бізнес в умовах тенденцій розвитку глобальних викликів