Learning objectives
Upon successful completion of the module of Pharmaceutical Manufacturing the student will acquire the knowledge related to organization, manufacturing and quality in the pharmacelutical industry.
In particular, the students will have to:
1) know and understand the organization and basic requirements for the manufacturing of medicinal products with specific emphasis on GMP (Knowledge and understanding);
2) know an understand some of the common processes used for the manufacturing of traditional dosage forms (Applying knowledge and understanding);
3) being able to apply the knowledge and independently evaluate which are the regulatory requests in terms of quality, efficacy and safety for traditional and advanced medicinal product (Applying knowledge and understanding).
Prerequisites
Students are required to take the exam of Pharmaceutical Technology
before sitting the exam of Pharmaceuticals Manufacturing.
Course unit content
The module of Pharmaceutical Manufacturing is offering to the students the knowledge related to the main regulation related to 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 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
The topics covered by Pharmaceutical Manufacturing teaching Module are:
- Intellectual Property Protection in the pharmaceutical field
- 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
- Manufacturing of products for gene therapy
- Packaging of medicinal products
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
L. FABRIS A. RIGAMONTI “La Fabbricazione Industriale Dei Medicinali” Societa’ Editrice Esculapio, Ed 2008
P. COLOMBO, P.L. CATTELLANI, A. GAZZANIGA, E. MENEGATTI, E. VIDALE "Principi di Tecnologie Farmaceutiche", 2° Ed. Casa Editrice Ambrosiana (2015).
Slides presented during classes will be available every week on Elly portal.
Teaching methods
Teaching is delivered via a series of lectures integrated with scientific papers, documents and online materials useful for the understanding and enrichment of the subject discussed in class.
All slides are made available online at the Elly website 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.
Lecture slides are made available online at the Elly website 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.Professionals from pharmaceutical companies will be invited to give specialistic lectures. This will offer to the students educational material up-to-date and to access knowledge closely connected to the requirements of the pharmaceutical industry.
Assessment methods and criteria
For students attending the module, an evaluation of their learning progression through a written test (30 MCQ, online, 60 minutes time) is offered at the end of the Module lectures. The test is generally delivered in presence, but it can be carried out online if restrictions related to the pandemic will be present.
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 within one week from the exam date.
Other information
Attendance to the lectures is compulsory (minimum 75% of the lectures). Working students are eligible for a reduction of the attendance requirements if officially registered.
Students with SLD/SEND should contact the Centro Accoglienza e Inclusione (http://cai.unipr.it) or the Department reference person (Prof.ssa Franca Zanardi
franca.zanardi@unipr.it - tel. +39 0521 905067)
