The legal support of quality of technological processes in the pharmaceutical industry of the Republic of Moldova

Abstract

Introduction. Of particular importance in ensuring the quality of technological processes and medicinal products is the legal support - all the legal acts and norms adopted in the vision of promoting and ensuring quality at all stages of production and distribution. According to ISO, quality requires all the performances and characteristics of a product or a care service determined by the ability to have a direct or implicit consumer satisfaction. The legal regulation of the quality of the technological processes in the pharmaceutical companies ensures the correspondence of the composition indicated on the label with the real one, by observing all the legal norms in force regarding: a. creation of the internal management system (ISO 9001); b. optimization of drug manufacturing (GMP); c. creation of the pharmaceutical quality system (ICH Q). Aim of the study. The aim is to raise awareness of the correct understanding of the concept of quality, to support the implementation of the quality management systems of technological processes. Materials and methods. As bibliographic sources served the Internet, the official data presented by amed.md. The research methodology used: analytical, statistical, comparison, etc. Results. The European legal regulations in the field studied represent respectively the standards of the ISO 9000 series, as well as the guides regarding their application in the ISO 10000 series (ISO 10006, for project management, ISO 10007 for management configuration, ISO 10013 for quality documentation, ISO / TR 10014 for quality economic efficiency management, audit and training standards). The quality management system of a pharmaceutical company is directly influenced by the national legal regulations, its objectives, by the pharmaceutical products delivered to the market and by its specific practices; as a result, quality systems vary from company to company. In the Republic of Moldova in 2013 the Order of the Ministry of Health, Labor and Social Protection, Nr. 309 of 26.03.2013 regarding the approval of the Rules of good manufacturing practice of medicines (GMP) for human use. In 1994, within the resolution on industrial competitiveness for the European Union, the Council of Ministers of the U.E. approved the initiative on the elaboration of a European quality promotion policy. On 01.01.2019 GMP certified 7 drug manufacturers in the Republic of Moldova. Conclusions. Due to the fact that there can be a mutual conditioning between the health of the citizens and the quality of the processes in the production of medicines and services, the state cannot remain indifferent to the way in which the problems of the quality of the products and services are solved, whether their realization is done in the private or state sector.