PHARMACEUTICAL LEGISLATION, PHARMACEUTICAL MANUFACTURING
Learning outcomes of the course unit
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 produts (Knowledge and understanding);
2) apply the knowledge to identify the specificities and to apply the correct procedures to fullfill 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).
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).
Students are required to take the exam of Pharmaceutical Technology
before presenting themselves to the exam of Pharmaceutical Regulations/Medicinal Products Manufacturing.
Course contents summary
The subject is organized in two separate Modules: the course of Pharmacy Legislation and the course of Pharmaceutical Manufacturing.
The module of Pharmacy Legislation is going to give the students an overview of the norms related to the Pharmacy profession and medicines dispensing. The module is divided in three parts:
1) A general introduction to pharmacy legislation including European regulations and directives on medicinal products and pharmacy profession, the Pharmacy guild and the National Healthcare System.
2) A second part dedicated to the administrative classification, procedures for the attribution of new pharmacies, pharmacy ownership, formal and unformal substitution of the pharmacy director.
3) The final part of the module is dedicated to the procedures for obtaining the manufacturing and marketing authorization for medicinal products, the classification of medicinal products and their dispensing, norms relative to over the counter products, veterinary medicinal products, herbal products, medical devices, in vitro diagnostics and cosmetics.
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.
Italian Healthcare system
Classification of pharmacies and distribution on the territory
Ethics of the pharmacist
Continuing Medical Education (CME)
Standards for the production and trade of human medicinal products (Marketing Authorization, Manufacturing Authorization)
Classification of medicines
Discipline dispensing the medicines to the public
Medicinal products not subject to medical prescription
Regulations for Veterinary Medicinal Products
Regulations for medical devices, in vitro diagnostics, biocides
Intellectual Property Protection in the pharmaceutical field
Medicinal Product Manufacturing
- Structure and organization of pharmaceutical plants
- Good manufacturing practices (GMP)
- Water for pharmaceutical productions
- Drying and Lyophilization
- Mixing of liquids
- Mixing of powders
- Capsules Manufacturing
- Manufacturing of sterile dosage forms
- Manufacturing of films
- Manufacturing of pMDI and DPI
- Manufacturing of radiopharmaceuticals
- Manufacturing of biopharmaceutical products
M. MARCHETTI, P. MINGHETTI: "Legislazione Farmaceutica", Casa Editrice Ambrosiana, Nona Ed. (2018)
M.CINI, P. RAMPINELLI
Principi di legislazione farmaceutica
Edizioni Minerva Medica, 2019
Fabbricazione Industriale dei medicinali
L. FABRIS A. RIGAMONTI “La Fabbricazione Industriale Dei Medicinali” Societa’ Editrice Esculapio, Ed 2008
Support texts available at the Pharmacy Library (Department of Food and Drug):
P. Colombo, P.L. Catellani, A. Gazzaniga, E. Menegatti, E. Vidale: "Principi di Tecnologie Farmaceutiche", 2° Ed. Casa Editrice Ambrosiana, Milano, 2015.
Farmacopea Ufficiale della Repubblica Italiana, XII Edizione, IstitutomPoligrafico e Zecca dello Stato, Roma (2008);
European pharmacopoeia 9 Ed. Strasbourg, Council of Europe, 2016
Copy of the slides presented during lessons will be made available weekly on the Elly portal (http://elly2020.saf.unipr.it/).
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.