Industrial Pharmacy and Laboratory of Pharmaceutical Technology
A.Y. 2021/2022
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.
Lesson period: First semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Single session
Responsible
Lesson period
First semester
During the emergency teaching phase, the course program, the reference materials and the training objectives will not change. More specific information on the delivery modes of training activities for academic year 2021/22 will be provided over the coming months, based on the evolution of the public health situation.
Course syllabus
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
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
Prerequisites for admission
For the part of industrial manufacture of medicines there is a written test consisting of about 20 questions with open and closed answers lasting 2 hours. To be admitted to the oral exam, the student must achieve a mark of at least 18/30. The result of the written test is communicated within ten days of its performance. The oral test consists of a discussion and possible integration of the topics covered in the written test; duration, about 20 minutes. For the laboratory part of pharmaceutical technology, a simulation of the shipment of a recipe of a masterful preparation is foreseen. To pass the test, the student must correctly identify the type of prescription required and indicate the related formalities, correctly describe the preparation of the master's preparation and the related quality controls, indicate in sufficient detail how to fill in the documentation required by the GMP.
Teaching methods
Regarding Fabbricazione Industriale dei Medicinali, due to Covid emergency, the course will be given by videoconference using MS Teams platform. Link to meeting room will be communicated on Ariel page.
The Laboratory course will be splitted in two parts: the first one will consist of a subsidy online lessons using Microsoft TEAMS ; the second part will be completed by doing in-person practicals in labs. If not possibile, all practices will be subsidy online.
A virtual classroom is set up where all students can attend the online lessons on the legislation that governs the practice of pharmacy in Italy. Only for these lessons it is not mandatory to have passed the qualifying exams reported on the "Manifesto degli Studi".
It is recalled that the frequency to all online classes and wet-lab activities is mandatory.
The Laboratory course will be splitted in two parts: the first one will consist of a subsidy online lessons using Microsoft TEAMS ; the second part will be completed by doing in-person practicals in labs. If not possibile, all practices will be subsidy online.
A virtual classroom is set up where all students can attend the online lessons on the legislation that governs the practice of pharmacy in Italy. Only for these lessons it is not mandatory to have passed the qualifying exams reported on the "Manifesto degli Studi".
It is recalled that the frequency to all online classes and wet-lab activities is mandatory.
Teaching Resources
Contents will remain unchanged and learning supports will be provided by ARIEL website.
Assessment methods and Criteria
For Fabbricazione Industriale dei Medicinali the exam will be oral and will take place in videoconference by using MS Teams platform. During the examination, students should demonstrate to have acquired an accurate and specific technological and regulatory language allowing them to communicate the most relevant topics in the field of Quality managment of drug manufacturing.
Regarding the exam of Laboratorio di Tecnica Farmacautica, If possible, the exam will consist in a written in-presence test. Alternatively, online oral exams will be held on MS Teams. All files required to duly deliver a medical prescription will be available in the virtual classroom on MS TEAMS.
Regarding the exam of Laboratorio di Tecnica Farmacautica, If possible, the exam will consist in a written in-presence test. Alternatively, online oral exams will be held on MS Teams. All files required to duly deliver a medical prescription will be available in the virtual classroom on MS TEAMS.
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
Professors:
Cerea Matteo, Foppoli Anastasia Anna, Franze' Silvia, Gennari Chiara Grazia Milena, Selmin Francesca
Shifts:
Turno 1
Professor:
Cerea MatteoProfessor(s)
Reception:
by appointment
via G. Colombo 71
Reception:
by appointment
Dept. Pharmaceutica Sciences - via G. Colombo, 71