Industrial Pharmacy and Laboratory of Pharmaceutical Technology

A.Y. 2019/2020
8
Max ECTS
96
Overall hours
SSD
CHIM/09
Language
Italian
Learning objectives
The course aims to impart in-depth knowledge of the technical regulations concerning the manufacturing and marketing authorization of drug products and to provide a critical understanding of the rationale behind these requirements. The practical activities envisaged in the laboratory are aimed at consolidating the knowledge acquired in the previous courses through the preparation and control of magistral and officinal formulae and the drafting of the relative documentation in compliance with the current laws.
Expected learning outcomes
At the end of the course the student must be able to understand and apply, critically and independently, regulatory requirements concerning the production and marketing authorization of industrial medicinal products. He will also have gained practical skills in the compounding of magistral and officinal formulae and acquired knowledge on the dispensation of medicinal products in pharmacies.
Course syllabus and organization

Linea Unica

Responsible
Lesson period
First semester
Industrial Pharmacy
Course syllabus
Integrated approach to drug development.
- Chemical-pharmaceutical, pharmaco-toxicological and clinical studies necessary for obtaining the Marketing Authorization (MA) for products containing new chemical entities.
- MA of medicines containing expired patent drugs.
- Production authorization (PA).
- Common Technical Document (CTD).
- Outlines of pharmaceutical patents, with particular regard to the aspects associated with the formulation and production of pharmaceutical forms.
- Structure and organization of a pharmaceutical plant.
- Personnel and Organization.
- Quality System and Compliance with Good Manufacturing Practices (NBF).
- Supplies of materials and services.
- Documentation.
- Risk management.
- Computerized systems.
- Premises, installations, equipment.
- Calibration, Qualification, Maintenance of the equipment.
- Validation of methods and processes.
- Production and Quality Control.
- Technology Transfer.
- Materials Management (storage and transport).
- Change Management.
- Management of deviations and non-conformities.
- Inspections and self-inspections.
Laboratory of Pharmaceutical Technology
Course syllabus
oral solid dosage forms
characterization of powders; preparation of mixtures; preparation and characterization of capsules; preparation and characterization of tablets
oral liquid dosage forms
preparation and characterization of solution; formulation of suspension; preparation and characterization of syrups
rectal dosage forms
preparation of suppositories with different suppository bases
cutaneous dosage forms
preparation of lipophic and hydrophilic creams, gels, ointments and pastes.

prescription assessment and legislation of pharmacy preparation
-justification of pharmacy preparation
-the prescription: legal requirement; narcotic and psychotic substances; substances included in the WADA prohibited list
-good laboratory practice
-labelling
Industrial Pharmacy
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Lessons: 32 hours
Professor: Cerea Matteo
Laboratory of Pharmaceutical Technology
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 4
Single bench laboratory practical: 64 hours
Shifts:
Turno 3
Professors: Cerea Matteo, Gazzaniga Andrea
Professor(s)
Reception:
by appointment
via G. Colombo 71
Reception:
By appointment
Dipartimento di Scienze Farmaceutiche, Sezione di Tecnlogia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71
Reception:
by appointment.
Dept. Pharmaceutica Sciences - via G. Colombo, 71