he expected learning outcomes are: theoretical and practical knowledge for the management of the industrial production of medicines in a national, European and international regulatory framework. Knowledge of the entire sequence of the complex multidisciplinary process that from Research and Development (RD), passing through different control systems and Quality Assurance (QA) leads to the production of drugs and medicines which will then be subjected to Quality Control (QC) to ensure their efficacy and safety. Also develop critical thinking and judgment skills in business management and production in a particularly critical area such as production in the pharmaceutical sector.
Course Prerequisites
Prerequisites: Pharmaceutical Technology and Legislation. Knowledge of the different pharmaceutical forms and routes of drug administration and of the basic principles of pharmaceutical technology.
Teaching Methods
The lectures will be supplemented by group research on current topics elaborated and discussed by the students,, moreover, some experts will be invited to show examples of industrial production techniques, facilities and business organization
Assessment Methods
Final written exam with 5-6 open questions. The exam aims to verify the learning of the skills necessary to manage pharmaceutical production at an industrial level. The following are therefore required: ability to understand the question, maturity of reasoning, connection, elaboration of meanings, flexibility in dealing with different topics and ability to communicate their contents.
Texts
Fabris L., Rigamonti A. LA FABBRICAZIONE INDUSTRIALE DEI MEDICINALI. Società Editrice Esculapio, Bologna, 2019. Lachman L., Lieberman H., Kanig J. THE THEORY AND PRACTICE OF INDUSTRIAL PHARMACY. Ed. Lea & Febiger, USA, 2008. Florence A.T., Attwood D. LE BASI CHIMICO FISICHE DELL’INDUSTRIA FARMACEUTICA. Ed. SES, 2002. P. Minghetti, M. Marchetti. LEGISLAZIONE FARMACEUTICA Casa Ed. Ambrosiana. Milano 2021. Brendan Cooper. THE GMP HANDBOOK: A Guide to Quality and Compliance; CreateSpace Independent Publishing Platform, 2017
Contents
Structure and organization of a pharmaceutical company: production plants, Good Manufactory Practices (GMP), Enterprise Resource Planning (ERP) and management of the information technology, batch production and documentation, strategies and criticalities of the production units, of the scale-up and validation processes, Standard Operating Practice (SOP), requirements of the environment, of the production premises, of personnel and security, inspections and self-inspections. Basics of patent law. Principles of pharmacoeconomics and health economics. Technical centralized services for the pharmaceutical industry, water and wastewater treatments, gases, steam, heat ventilation and air conditioning system. Unitary processes in the pharmaceutical production, filtration, grinding, mixing, drying: theory, technologies, methods and equipments. Manufacturing of liquid, solid and semisolid dosage forms. Equipment for terminal sterilization, production in sterile conditions and related controls. Freeze drying. Blow-fill-seal technology. Packaging.
