67133 - Regulatory environment and industrial production

Learning outcomes

At the end of the course the student will have adequate knowledge of the national and EU legislation on environmental protection and human health. In particular, regulations on chemicals, water, emissions into the environment of industrial origin or related to mobility, solid waste, electromagnetic and non-electromagnetic radiation. Furthermore, he knows notions concerning the main operations and equipment used in the pharmaceutical and health industrial production, starting from the regulatory aspects up to the analysis of industrial and environmental risks.

Course contents

Environmental legislation (Dr. Leonardo Marchitto) (mod I)


the module offers an in-depth overview of the nature and management of substances used by industry that can produce dangerous emissions to air, water and soil and some physical health risks associated with environmental conditions, such as noise and fields electromagnetic. These key themes are directly linked to the United Nations 2030 Agenda for Sustainable Development, with particular regard to: good health and well-being (3); degradation of water resources (6) - clean water and sanitation); industrial innovation, green chemistry and circular economy (9 - industry, innovation and infrastructure); climate change (13 - climate action)

General principles underlying international law, biodiversity, the sources of Italian and EU law; The multilevel governance system for environmental protection: Local, Regional and National Authorities, Ministry of the Environment and Land and Sea Protection, ISPRA, ANPA ARPA, civil protection

Mineral waters (Legislative Decree 176/2011 - D.M. 11/09/2003 and 10/02/2015), water intended for human consumption (drinking water) (L.31/01), swimming pools (Decision of the Emilia Romagna Region Council n 1092/2005), waste water. Rainwater, Classification and treatment of discharges, Authorization and control of discharges; Legislative Decree 152/06 (Environmental Protection Code) - Part III.


Classification of emissions into the atmosphere, Policy on greenhouse gas emissions. Solvent management plan (PGS), Emissions from thermal plants, Authorization and control of emissions into the air; Legislative Decree 152/06 (Environmental Protection Code) - Part V


Categories and classification of the danger of waste, Handling and marketing of waste, Methods of waste disposal and principles of the circular economy, Transport of waste, Authorizations and control of waste, Remediation of asbestos as a special case; Legislative Decree 152/06 (Environmental Protection Code) - Part IV


Transport of dangerous goods (ADR)


General requirements for occupational health and safety, Introduction to the tasks of the main actors for the prevention of occupational accidents and diseases, Chemical risk assessment; Legislative Decree 81/08 ((Title I-Part III and Title VIII-Part II)


Risk of major accidents (Seveso Directive)


Noise pollution, Physical behavior and psychophysical aspects of noise, Noise descriptors, Protection of workers from noise in the workplace; Law 447/95 Framework law on noise pollution; DPCM 11/14/1997 Determination of limit values of sound sources; Legislative Decree 81/08 (Title VIII-Part II)


Electromagnetic pollution; Electromagnetic fields descriptors (EMC), Protection of workers from EMF in the workplace, Law 36/01 Framework law on pollution from electromagnetic fields; Legislative Decree 81/08 (Title VIII-Part IV)


The authorization system: Environmental impact assessment (VIA) and Integrated control of prevention and pollution-Integrated Environmental Authorization- AIA), Strategic environmental assessment (Strategic Environmental Evaluation), Single environmental authorization (Single Environmental Authorization); Legislative Decree 152/06 (Environmental Protection Code) - Part II


Regulations of medicines production and healthy products (Dr. Leonardo Marchitto) (mod II)


Harmonized European standards and product policy


The Technical Standards (ISO Standards, UNI etc)


The ISO 9001, ISO 17025, HACCP and GMP quality management systems.


Industrial-level product quality and safety concepts for pharmaceuticals: Pharm Monograph. Eur. n°2034 “Substance for Pharmaceutical Use”. Organic impurities, genotoxic impurities, residual solvents, elemental impurities. API quality, EDMF (European Drug Master File), COS/CEP. Quality of excipients used.


Concepts of quality, safety and biocompatibility of products at an industrial level for Medical Devices and cosmetic products


Concepts of quality and safety of nutraceutical products
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Readings/Bibliography

lecture notes, teacher slides

Teaching methods

university lecture

Assessment methods

oral exam on the two modules

Teaching tools

Word , Excel , PowerPoint , links to web pages in the environmental and Pharmaceutical, Health fileds

Office hours

See the website of Leonardo Marchitto