PHARMACEUTICAL MANUFACTURING
cod. 1004486

Academic year 2022/23
4° year of course - First semester
Professor
- Carsten EHRHARDT - Fabio SONVICO
Academic discipline
Farmaceutico tecnologico applicativo (CHIM/09)
Field
Discipline chimiche, farmaceutiche e tecnologiche
Type of training activity
Characterising
40 hours
of face-to-face activities
5 credits
hub: PARMA
course unit
in ITALIAN

Learning objectives

The teaching module of Pharmaceutical Manufacturing is an advanced pharmaceutics course aiming at providing basic knowledge for the understanding of the Pharamaceutical industry and Market.
Specifically, the student will have to demonstrate:
1) Knowledge of the structure of pharmaceutical industries and basic requirements for manufacturing and marketing of medicinal products, including GMP (Knowledge and understanding);
2) Understand the manufacturing processes of some of the traditional and advanced dosage forms (Knowledge and understanding);
3) Understand and evaluate the regulatory requirements (quality, efficacy, safety) of most common ad advanced dosage forms (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 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


Structure and organization of pharmaceutical plants
Good manufacturing practice
Validation
Freeze Drying
Milling/Micronization
Capsules Manufacturing
Manufacturing of inhaled medicinal products (nebulization, pMDI, DPI) – Prof. Carsten Ehrhardt, TCD, Ireland
Manufacturing of sterile dosage forms
Manufacturing of radiopharmaceuticals
Manufacturing of biological/biotecnological products
Manufacturing of avanced therapy products
Packaging

Bibliography

L. Fabris A. Rigamonti
La Fabbricazione Industriale Dei Medicinali
Societa’ Editrice Esculapio, Ed 2008

P.Colombo, F.Alhaique, C.Caramella, B.Conti, A.Gazzaniga, E.Vidale
Principi Di Tecnologie Farmaceutiche. Seconda Edizione.
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 (uploaded on the portal Elly).

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. 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.

The lectures related to inhalation medicinal products will be given by the Visiting Professor Carsten Ehrhardt, Trinity College Dublin (Ireland).
The participation to the lessons is compulsory.

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 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 lectures is compulsory (minimum 75% of the lectures).

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)