Learning objectives
Upon successful completion of the module of Pharmacy Legislation the student will acquire the knowledge related to the norms regulating the Pharmacy profession.
In particular, the students will have to:
1) know and understand the legislation that regulate the Pharmacy profession and the dispensing of medicinal products (Knowledge and understanding);
2) apply the knowledge to identify the specificities and to apply the correct procedures to fulfil the most common medical prescriptions (Applying knowledge and understanding);
3) being able to integrate new national and European legislation with the acquired knowledge (Learning skills).
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
- Packaging of medicinal products
Bibliography
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 (http://elly.saf.unipr.it).
Teaching methods
Teaching is delivered via a series of lectures (mixed modality of teaching in presence/online streaming, at least until in presence attendance to classes will not be possible) 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.
Lecture 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.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 (https://unipr.esse3.cineca.it/Home.do) within one week from the exam date.
Other information
Attendance to the Module is compulsory (minimum 75% of the lectures).
