67133 - Regulatory environment and industrial production

Learning outcomes

At the end of the course, the student has adequate knowledge of national and EU regulations 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. He also knows notions concerning the main operations and equipment in use in industrial pharmaceutical and health production starting from the regulatory aspects up to the analysis of industrial and environmental risks.

Course contents

Environmental and Industrial Production Regulations Program


MODULE I PROGRAM (Environmental Legislation; Dr. Leonardo Marchitto)

Introduction to environmental legislation; General principles of national and community law; The sources of national and community environmental legislation; Responsibilities of the public administration, the ministry of the environment; ISPRA, ARPA, APPA; Civil protection; The competences of the Region - Province - Municipality in environmental matters; Waste management; Regulations: Legislative Decree 152/2006 and subsequent amendments; Waste categories; Packaging; WEEE; Waste disposal, MUD and SISTRI; Water pollution; Discipline of discharges. Regulations: Legislative Decree 152/2006 and subsequent amendments; Classification of discharges. Rainwater; Control of discharges and authorization regime. Air pollution; Regulations: Legislative Decree 152/2006 and subsequent amendments; The authorization system, controls; thermal plants; Air pollution, reduction of CO2 emissions; Waters; Mineral waters, water intended for human consumption; Swimming pools. Electromagnetic pollution; Noise pollution; Framework law on noise pollution: Law 26 October 1995, n. 447; D.P.C.M. November 14, 1997: Determination of the limit values of sound sources; noise in the workplace. Environmental Impact Assessment (V.I.A.); EIA, SEA, and AIA integrated environmental authorization procedures. Work environment 81/08; Protection of health and safety in the workplace


MODULE II PROGRAM (Industrial production regulations; Dr. Leonardo Marchitto)

European harmonized standards and product policy; Technical regulations (ISO, UNI, etc); The quality management systems ISO 9001, ISO 17025, HACCP and GMP .; Concepts of quality and safety of products at industrial level for pharmaceutical products: Monograph Pharm. Eur. No. 2034 "Substance for Pharmaceutical Use". Organic impurities, genotoxic impurities, residual solvents, elemental impurities. Quality of the API, EDMF (European Drug Master File), COS / CEP. Quality of the excipients used; ERA risk assessment; Concepts of quality, safety and biocompatibility of industrial products for medical devices; Concepts of quality and safety of nutraceutical products and food supplements; Concepts of quality, safety of products at industrial level for cosmetic products.

Readings/Bibliography

notes and slides from the lessons

Teaching methods

formal lessons , on line lessons 

Assessment methods

oral examen

Teaching tools

powerpoint; 

Office hours

See the website of Leonardo Marchitto