In this paper, the approaches to optimizing the environmental management system at pharmaceutical manufacturing enterprises and the environmental policy of pharmaceutical corporations in general were proposed. In the course of the study, it has turned out that the indicators of the negative impact on the environment as a result of the economic activities of industrial pharmaceutical enterprises do not take into account all the specific features of technological processes. At modern pharmaceutical enterprises, direct environmental risks are minimized at working areas and, in fact, their assessment is replaced by the calculation of barrier and isolation measures, which is in the competence of calculating sanitary and epidemiological risks only for employees of enterprises. In the course of pre-design, design work and the creation of pharmaceutical manufacturing enterprises, owing to the requirements and mandatory application of GxP, in fact, the negative impact on the environment at the enterprise itself within the boundaries of its sanitary zone is reduced to zero. However, a number of questions remain to be resolved, including how and to what extent a pharmaceutical business entity, in the course of its activities, causes a negative impact on the environment outside its location. With this article, we begin series of publications of the results of our research in the direction of multilateral analysis of environmental risks in pharmaceutical organizations of different profiles and groups of pharmaceutical companies, united into separate corporate companies. Compared to those approaches to assessing environmental risks as a result of the activities of pharmaceutical manufacturing enterprises, which are mainly focused on meeting the GxP requirements and relate to the quality of manufactured pharmaceutical products, we propose to take into account information with an emphasis, inter alia, on the energy saving policy of the Russian pharmaceutical industry. The main goal of an integrated approach to the development of environmental policy and environmental management system in the pharmaceutical industry is for the management of manufacturing enterprises to comprehensively monitor and assess all environmental risks and energy conservation, in particular, taking into account the provision of energy efficiency to reduce the negative impact on the environment.

The report presents the results of a review and discussion on providing qualified personnel for radiation medicine facilities and suggests approaches to personnel training. Qualified personnel availability comes first among the principles of quality control of radiopharmaceuticals (RP), supply of modern equipment, access to up-to-date regulatory documents, validated control methods and the organization of internal audit system. Also, radiation medicine facilities workers are inevitably exposed to harmful hygienic factors of the working environment throughout the entire life cycle of RP: the development, testing, production and civil circulation. Nuclear and radiation medicine facilities place the environment at risk of negative impact. Highly qualified specialists (responsible parties) should have knowledge, skills and abilities provided by special basic education are required to assess sanitary, hygienic and environmental risks and to comply with the quality management system requirements for the stable operation of radiation medicine facilities.