On the conceptual project of an environmental management system at a pharmaceutical biotechnology enterprise

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Abstract

In our opinion, the ability to prevent or avoid negative impact on the environment by pharmaceutical industry organizations in normal situations fully depends on the environmental management system of the quality management system of the production enterprise. During the work, according to the set goals and objectives, an analysis of the accounting and reporting documentation of pharmaceutical manufacturers was carried out based on environmental international and domestic regulatory acts and documents in the paradigm of sustainable development. We have proposed a Conceptual project of an environmental management system in the form of a block diagram of nature conservation documentation for category II hazardous waste facilities of pharmaceutical biotechnology enterprises. Individual documents and document templates were developed in such a way as to cover the most common accounting and reporting documents filled out by a pharmaceutical industry production enterprise based on principles of social responsibility in environmental protection. It is necessary to note the relevance of introducing and balancing non-financial and financial reporting in the quality management system of pharmaceutical production enterprises, taking into account their social responsibility and personnel work. The results obtained can be used in the quality management system of pharmaceutical industry organizations - drug manufacturing enterprises using biological and chemical technologies when implementing projects during the development of nature conservation documentation for environmental management system projects with the aim of developing a project for social responsibility and non-financial reporting, not just for public joint-stock companies.

About the authors

Vladimir V. Perelygin

Saint Petersburg Chemical and Pharmaceutical University of the Ministry of Health of the Russian Federation

Email: vladimir.pereligin@pharminnotech.com
ORCID iD: 0000-0002-0999-5644
SPIN-code: 3128-7451
Scopus Author ID: 13105602000
ResearcherId: AAV-6556-2020

Doctor of Medicine (MD), Professor, Head of the Industrial Ecology Department

Russian Federation, Saint Petersburg

Vitaly A. Sakharov

Saint Petersburg Chemical and Pharmaceutical University of the Ministry of Health of the Russian Federation

Author for correspondence.
Email: vitalij.saharov@spcpu.ru

Master’s student of the Department of Industrial Ecology

Russian Federation, Saint Petersburg

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2. Fig. 1. Block diagram for a category II hazardous waste facility

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