Big medicine manufacturers find meeting the specific needs of a small number of patients unprofitable because they imply the production of only a few packages of medicines in an expensive and sophisticated system of Good manufacturing practice (GMP). Therefore, there is a specific niche for such patients in smaller laboratories of both private and public healthcare pharmacy establishments, and their needs can be met with relatively small financial investments beyond the cost of starting a business. However, there are problems with this because of the incomplete and legally non-binding nature of conditions for the preparation of medicines in healthcare establishments. This topic has been the subject of discussion by numerous professional and regulatory authorities. Following a detailed review of the relevant literature, this paper introduces the topic of development and introduction of quality systems in smaller laboratories of pharmacy healthcare establishments. The introduction of a quality system would precisely define the obligations of the establishments, the role of pharmacists as key health professionals in pharmaceutical preparation, as well as the appropriate implementation and documentation of all procedures included. It would ensure the preparation of effective and high-quality preparations for the specific needs of individual patients. OBJECTIVES The objective of the thesis is to explain the need of establishing a quality system for pharmaceutical preparations. It will be achieved by studying relevant literature and guidelines and summarizing regulations related to the pharmaceutical preparations (galenic and magistral/stock and extemporaneous preparations) prepared in pharmacy healthcare establishments. MATERIAL AND METHODS Research within this paper is of theoretical nature. The paper is primarily focused on the review, development and interdependence of relevant legal and professional regulations in the Republic of Croatia, other countries of the European Union and the United States. The paper handles the topic of the quality system of smaller laboratories from the concept of risk management in the life cycle of a pharmaceutical preparation through the review of their regulations in individual countries. The thesis comprises what has been discussed at events relative to the adoption of guidelines of the Council of Europe's Resolution CM / Res from 2016 and PIC/C's Guide to good practices for the preparation of medicinal products in healthcare establishments. These international guidelines are compared with professional guidelines in the laboratories of pharmaceutical healthcare establishments in the Republic of Croatia. RESULTS The current regulations of the Republic of Croatia poorly define the conditions in which the preparation of a small series of galenic and individual magistral preparations should take place. Elaboration and development of laws and guidelines will provide health professionals in this area a clearer insight into the structure of quality systems and practices of pharmaceutical preparation in other countries. In this way, healthcare professionals will be able to better understand key concepts, such as risk control and product life cycle, as well as the requirements they must fulfill in order to produce pharmaceutical preparations of satisfactory quality and expected therapeutic outcome for specific individual patient needs. CONCLUSION In order for pharmacy healthcare establishments to introduce a quality system for the purpose of medicine preparation, all healthcare establishment's management and staff must contribute to the development of the necessary quality system elements. The paper presents and explaines examples of quality assurance system structures that healthcare establishments can use depending on their strategic planning, as well as a specific plan for introducing a quality system in pharmacy healthcare institutions through phases of preparation, planning, and implementation.