LEARNING OUTCOMES OF THE COURSE UNIT
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 Pharmacy Legislation/Industrial Manufacturing of Medicines.
COURSE CONTENTS SUMMARY
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 practice and quality by design and providing practical examples related to the manufacture of a number of dosage forms.
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
ASSESSMENT METHODS AND CRITERIA
As an optional opportunity of evaluation, to students attending the lesson is proposed an evaluation of the semester learning through written test (MCQ) at the end of the teaching of each module. The test consists in multiple choice questionnaire.
In alternative an evaluation via oral examination is also possible at the exam sessions.
The module is taught through 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 (elly.saf.unipr.it). Slides are a integral part of the studying material.
Students will be constantly reminded the appropriate technical language, exposed to professional case studies, 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.
An attendance at least of 75% of lectures is required, while the frequency of all the laboratory sessions is compulsory.
- Structure and organization of pharmaceutical plants
- Good manufacturing practice
- Water for pharmaceutical productions
- Mixing of liquids
- Mixing of powders
- Capsules Manufacturing
- Manufacturing of sterile dosage forms