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

Linea Unica
Responsible
Lesson period
First semester
Syllabus
The course is aimed at deepening the knowledge relating to the regulatory aspects concerning the registration and industrial manufacture of medicines and to provide students with basic notions on organization, equipment, methodologies and terminology usually adopted. Laboratory activities are aimed to the acquisition of practical experiences concerning: general pharmaceutical operations; the preparation of dosage forms; quality control of dosage forms according to Pharmacopoeia; the preparation of the documentation required by the Good Compouning Practices.
Acquisition of knowledge concerning the dispensing of medicines in Pharmacy.
Regarding the part of industrial manufacturing of drug products the course will discuss about the GMP guidelines and in details:
- 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.
Prerequisites, exams and assessment
Basic knowledge on inorganic and organic chemistry
Teaching methods
For the part of pharmaceutical technology laboratory: training sessions in laboratory provided with individual workstations
For the part of industrial manufacturing medicinal products: frontal lessons
Teaching resources and bibliography
slides will be available on ARIEL website and http://users.unimi.it/gazzalab/studenti/
lab handouts (part 1 + part 2) will be available on ARIEL website
Minghetti P. - Legislazione Farmaceutica, CEA, IX ed., 2018
P. Colombo, P.L. Catellani, A. Gazzaniga et al., Principi e Tecnologie Farmaceutiche, CEA, Milano (2007).
Exam
The exam consists in two parts. Regarding the Laboratory of Pharmaceutical Technology, the written test deals with the simulation of dispensing (a prescription of) a galenic medicinal product (magistral or officinal) in order to evaluate the theoretical and practical knowledge acquired during the practical session. The test will last 3 hours and "Tabelle" from the Italian Pharmacopeia and relevant updates will be provided. To pass the exam (18/30), the student is required to determine the correct prescription regimen and to indicate the formalisms as per the current national legislation; to describe the compounding operations and quality controls to be carried out according to the Good Compounding Practice; to fill in the label and the documentation to be stored in pharmacy. Within 12 months, the student has to the pass the second written test.
For the part of industrial manufacturing of medicinal products the examination consists of a written an oral exam. The written test includes about 20 open and closed questions in a time of 2 hours. In order to be admitted, to the oral exam the student must obtain a mark of at least 18/30. The result of the written test is communicated within ten days from the exam session. The oral test consists of a discussion and possible integration of the topics covered in the written test; duration, about 20 minutes.
The final mark is calculated as weighted average of the single marks.
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