Learning objectives
Upon successful completion of the module of Pharmaceutical Manufacturing the student will acquire the advanced knowledge in pharmaceutics and the basics concepts to understand the world of Pharmaceutical companies.
In particular, the students will have to:
1) Know and understand industry organization and the fundamental requirements of pharmaceutical manufacturing, through the knowlege of the GMP (Knowledge and understanding);
2) Be acquainted with the manufacturing processes of the most common dosage forms (Knowledge and understanding);
3) Be able to understand and autonomously evaluate the risks and regulatory requirments in terms of quality, efficacy and safety of the most common pharmaceutical manufactuting procesess (Applying knowledge and understanding).
Prerequisites
Students are required to take the exam of Pharmaceutical Technology before presenting themselves to the exam of Industrial Manufacturing of Medicines.
Course unit content
The module of Pharmaceutical Manufacturing is offering to the students the knowledge related to the norms regulating the manufacturing of medicinal products and directed to make available to the public medicines with the highest standard of quality, safety and efficacy. In order to achieve this goal the course will provide the basic concepts on the current regulations and modern manufacturing approaches for the production of medicinal products starting from intellectual property protection, addressing Good Manufacturing Practices (GMPs) and Quality-by-Design and providing practical examples related to the manufacture of a number of dosage forms.
Full programme
- Structure and organization of pharmaceutical plants
- Good manufacturing practices (GMP)
- Validation
- Water for pharmaceutical productions
- Drying and Lyophilization
- Mixing of liquids
- Mixing of powders
- Filtration
- Milling
- Tabletting
- Capsules Manufacturing
- Manufacturing of sterile dosage forms
- Manufacturing of films
- Manufacturing of pMDI and DPI
- Manufacturing of radiopharmaceuticals
- Manufacturing of biopharmaceutical products
- Packaging
Bibliography
L. Fabris A. Rigamonti
LA FABBRICAZIONE INDUSTRIALE DEI MEDICINALI
Societa’ Editrice Esculapio, Ed 2008
P.Colombo, P.L.Catellani, A.Gazzaniga, E.Menegatti, E.Vidale
Principi di tecnologie farmaceutiche.
Editore: Casa Editrice Ambrosiana, 2015
Teaching methods
Teaching is delivered via a series of lectures (mixed modality of teaching in presence/online streaming) integrated with scientific papers, documents and online materials useful for the understanding and enrichment of the subject discussed in class (uploaded on the portal Elly, elly2020.saf.unipr.it).
All slides are made available online at the Elly website (elly2020.saf.unipr.it) where videorecordings of lectures will be available for a limited time (7 days).
Students will be constantly reminded the appropriate technical language, exposed to real-life profession examples, invited to understand the underlying connections between different parts of the course and other subjects and will be stimulated to actively participate to the lectures with interactive discussions.
Assessment methods and criteria
For both the modules, students attending the course are offered during the semester an evaluation of their learning progression through written tests (30 MCQ, online, 60 minutes time) at the end of the teaching of each module. The results of the test will constitute the basis for the final exam evaluation where the oral exam will be a discussion of test results.
For students not taking the tests or not satisfied with the test results the final exam will be an in depth oral exam (3 questions on Parmaceutical Regulations and 3 questions on Medicinal Products Manufacturing) in presence or online according to the student preference.
Students can register online for the exam using portal ESSE3 (https://unipr.esse3.cineca.it/Home.do) in the sessions available on the official exams calendar of the Dipartimento di Scienze degli Alimenti e del Farmaco.
Exams results are announced at the end of the oral exam and are availale online at ESSE3 portal (https://unipr.esse3.cineca.it/Home.do) within one week from the exam date.
Other information
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