PHARMACEUTICAL LEGISLATION, PHARMACEUTICAL MANUFACTURING

Credits: 
10
Site: 
PARMA
Year of erogation: 
2023/2024
Unit Coordinator: 
Semester: 
First semester
Language of instruction: 

italian

Modules: 

Learning outcomes of the course unit

The first module of Pharmaceutical Regulations will provide an in-depth knowledge of the pharmaceutical legislation concerning, in particular, the practice of community pharmacists who directly provide the essential pharmaceutical service to the citizens or the pharmacist who works in contexts indirectly related to the pharmaceutical service.

The second module of Medicinal Products Manufacturing wants to provide an introduction to the classic processes of the manufacturing of pharmaceuticals with a special attention devoted to the
aspects that can be considered critical for the quality of the medicinal
product.

Prerequisites

Students are required to take the exam of Pharmaceutical Technology
before presenting themselves to the exam of Medicinal Products Manufacturing.

Course contents summary

The fists section of the first module is devoted to general presentations related to European regulations, Italian Healthcare system and Health professions registries.
The second part of the first module is dedicated to the administrative classification of pharmacies, public selection for the allocation of new pharmacies, informal and formal substitution of pharmacy owner, temporary administration, professional ethics of the pharmacist, continuing Medical Education (CME).
The final section of the first module is dealing with required standards for the production and trade of human medicinal products, classification of medicinal products, pharmacopoeias, dispensing of medicinal products subject to prescription to the public, medicinal products not subject to medical prescription, regulations specific for veterinary medicinal products, regulations for medical devices.

The second module will treat arguments of industrial production of medicines, starting from the industrial organization to the description of the unit operations for dosage forms manufacturing and medicines preparation.
Detailled descriptions of operations and dosage forms manufacturing will
be provided. The knowledge functional to the understanding of the processes linked to the pharmaceutical product manufacturing necessary for the attainment of products having the required safety, efficacy and quality.

Course contents

I MODULE
International regulations
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 medicinal products for human
Classification of medicines
Pharmacopoeias
Discipline dispensing the medicines to the public
Medicinal products not subject to medical prescription
Regulations for Veterinary Medicinal Products
Regulations for medical devices,
Pharmacovigilance

II MODULE
- Structure and organization of pharmaceutical plants
- Good manufacturing practice
- Validation
- Water for pharmaceutical productions
- Drying
- Mixing of liquids
- Mixing of powders
- Filtration
- Milling
- Tabletting
- Capsules Manufacturing
- Manufacturing of sterile dosage forms
- Packaging

Recommended readings

I MODULE:
M. MARCHETTI, P. MINGHETTI:
"Legislazione Farmaceutica",
Casa Editrice Ambrosiana, Ed. 2015

FARMACOPEA UFFICIALE ITALIANA XII ed.
IstitutoPoligrafico dello Stato; Farmacopea Europea

II MODULE:
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

Teaching methods

Both modules are taught with traditional lectures with the aid of computer tools providing to the students teaching material

Assessment methods and criteria

For both the modules to students attending the lesson is proposed an evaluation of the semester learning through written test 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.