Catalogo dei Corsi di studio

General expected learning outcomes
The Industrial Manufacturing of Medicines course aims to provide the knowledge related to industrial plant engineering, to the production processes of drugs, to the Good Manufacturing Standards and to provide the knowledge of the pharmaceutical technologies used in the production and packaging of medicines. in the industrial field, according to the specifications of which, both plants and products, must comply with regulations in compliance with a quality production imposed by the authorities responsible for the control of the pharmaceutical supply chain. The course in accordance with the Integrated Didactics (PDI) projects aimed at improving the quality of the educational offer, with additional teaching modules of an interdisciplinary nature that provide for the intervention of external faculty members, the use of information technology, telematics and multimedia the continuation of the work already underway for the organization of training and training stages which have represented, for students and undergraduates, a moment of professional growth and comparison with the world of work and industry. In addition to the Official Course will be carried out, (PDI), supplementary teaching modules, additional to the ordinary teaching activity. One of the main objectives of the degree course in Chemistry and Pharmaceutical Technologies is to prepare an employee for the pharmaceutical industry. In this context the Industrial Manufacturing of Medicines module has a preferential application location with the purpose of applying the principles of pharmaceutical technology to the industrial production of drugs.

Specific expected learning outcomes
1. Knowledge and understanding
The regulatory, technological, process and plant engineering knowledge required to operate with high qualification in the manufacturing industry of traditional and biotechnological medicines is acquired.
The competencies in the GMPs and regulatory, technological, process and plant engineering fields are acquired, necessary to operate with high qualification in the production industry of traditional and biotechnological medicines both for the dosaged forms and for APIs (Active Principles Ingredients).

2. Applying knowledge and understanding
At the end of the course the student will be able to apply the knowledge of what has been learned according to the specific topics indicated in detail and dealt with in the course program in the chemical-pharmaceutical and nutraceutical industry in accordance with EMA and FDA regulations.

3. Making judgements
The lectures will be interactive with specialized seminars and with the intervention of qualified people (QP, QA, QC etc) coming from the world of the chemical-pharmaceutical industry.

4. Communication skills
The ability to communicate what has been learned is put in place with an interview, participating in a team at the production and technological R & D organization of chemical-pharmaceutical companies.

5. Learning skills
The ability to communicate what has been learned is implemented with the oral exam and with the presentation of papers on specific topics agreed between the teacher and the student. The student must discuss the term with a PowerPoint presentation during the exam.
After passing the exam, the student will have acquired technical-scientific knowledge and regulatory and regulatory references specific to the world of the drug industry and will be able to start an autonomous path of professional growth by interfacing with the world of work.

Programme

Part 1 (20 hrs)
Industry Authorization for medicine production (AP): LEGISLATIVE DECREE no. 219 of 24 April 2006 and subsequent updates
Good Manufacturing Practices (NBF) and Good Manufacturing Pratices (GMP): EU directive 2017/1572 OF THE COMMISSION OF SEPTEMBER 15, 2017 subsequent updates
Annex1
Inspections
Process Analytical Technology (PAT)
Patents
National and supranational institutions
Notes on marketing authorization (AIC), revocation and suspension: procedures AIC for requesting ; common technical document (CTD).

Part 2 (22 hrs)
Structure and organization of a pharmaceutical plant: design, construction, organization-organization chart. Control and acceptance of incoming material
Technical services: steam, water, electricity. Water: purified, for injectable preparations, production technologies, treatments and conditioning.
Clean rooms: regulatory requirements, air sterilization, classification of sterile rooms, operating personnel clothing, glove boxes, Cleaning Validation

Part 3 ( 10 hrs)
Preparation of solid dosage forms
Preparation of liquid dosage forms
Preparation of semi-solid dosage forms.
Packaging

Part 4 (12 hrs)
OUTLINES AND PRACTICAL ASPECTS RELATED TO NON-CONVENTIONAL DOSAGE FORMS: SCALE UP, CROSS CONTAMINATION, HANDLING, STAFF

Adopted texts

Fabbricazione Industriale dei medicinali L.FABRIS- A.RIGAMONTI, ESCULAPIO
Legislazione Farmaceutiche P. MINGHETTI EDIZIONE CORRENTE
Legislazione Farmaceutiche nella pratica professionale G.BARBERINI- L. CASETTARI, PICCIN
FARMACOPEA ITALIANA e suoi aggiornamenti
FARMACOPEA EUROPEA

Prerequisites

Prerequisites In order to ensure a sufficient level of learning, the student must have acquired knowledge of physical chemistry and Pharmaceutical Technologies and legislation. In addition, basic knowledge of formulation processes and some aspects about the methods of characterization of dosage forms are needed. In particular, it is required a basic knowledge of the conventional and innovative dosage forms. This knowledge is important for the multidisciplinary nature of the course and to the understanding of technologies applied to industrial production processes. In this regard, a study of the basic concepts and useful approaches to drug delivery is suggested. Some of these aspects will be anyhow highlighted at the beginning of the course.

Study modes

In accordance with the instructions of the University, reported at https://www.uniroma1.it/it/notizia/covid-19-fase-3-lezioni-esami-e-lauree-presenza-e-distanza, the lectures of the courses of all study courses (first degrees, master's degrees, doctoral courses, masters) are in presence, to the extent of 100% of the places originally usable for each classroom , also guaranteeing remote use to allow the participation of those who cannot secure a place in the classroom and / or for health reasons will not be able to participate in face-to-face activities. The students will be divided in small groups and then it will be requested to apply, according to a more practical approach, the information acquired during the first part of the lesson. The lessons, that will be carried out “in presence”, will be supplemented with further explanations and checks following an applicative point of view. For a deeper insight, experts in the specific fields faced during the lessons will be invited.

Frequency modes

Non mandatory attendance

Exam modes

It will be proposed to the students (individually or in group) to develop a research which, taking into account the topics faced during the course, includes the various aspects related to the production and control of medicines, including the legislative point of view. If needed, a written paper will also be requested ( open answers).
A minimum score of 18/30 is needed to pass this exam.
As far as the overall evaluation of the exam is concerned, the final score will take into consideration how much the students are acquainted with the topics faced during the course, the logical evolution of the presentation of the proposed project as well as the skill and competences that were acquired. The use of appropriate terminology during the presentation will also play an important role.
Together with a check of the acquisition by the student of most aspects of the project proposed for the exam, it will be evaluated how wide and deep he/she is capable of discussing appropriately and logically the specific topic and to identify the noteworthy points of the problem that is faced.

Programme

Part 1 (20 hrs)
Industry Authorization for medicine production (AP): LEGISLATIVE DECREE no. 219 of 24 April 2006 and subsequent updates
Good Manufacturing Practices (NBF) and Good Manufacturing Pratices (GMP): EU directive 2017/1572 OF THE COMMISSION OF SEPTEMBER 15, 2017 subsequent updates
Annex1
Inspections
Process Analytical Technology (PAT)
Patents
National and supranational institutions
Notes on marketing authorization (AIC), revocation and suspension: procedures AIC for requesting ; common technical document (CTD).

Part 2 (22 hrs)
Structure and organization of a pharmaceutical plant: design, construction, organization-organization chart. Control and acceptance of incoming material
Technical services: steam, water, electricity. Water: purified, for injectable preparations, production technologies, treatments and conditioning.
Clean rooms: regulatory requirements, air sterilization, classification of sterile rooms, operating personnel clothing, glove boxes, Cleaning Validation

Part 3 ( 10 hrs)
Preparation of solid dosage forms
Preparation of liquid dosage forms
Preparation of semi-solid dosage forms.
Packaging

Part 4 (12 hrs)
OUTLINES AND PRACTICAL ASPECTS RELATED TO NON-CONVENTIONAL DOSAGE FORMS: SCALE UP, CROSS CONTAMINATION, HANDLING, STAFF

Adopted texts

Fabbricazione industriale dei medicinali L.FABRIS- A.RIGAMONTI, ESCULAPIO
Legislazione Farmaceutiche P. MINGHETTI EDIZIONE CORRENTE
Legislazione Farmaceutiche nella pratica professionale G.BARBERINI- L. CASETTARI, PICCIN
FARMACOPEA ITALIANA e suoi aggiornamenti
FARMACOPEA EUROPEA
Teaching and didactic materials (slides, scientific reports)

Bibliography

Updated scientific articles provided by the teacher

Prerequisites

Prerequisites In order to ensure a sufficient level of learning, fundamental for the student is the acquisition of knowledge of physical chemistry and Pharmaceutical Technologies and legislation. In addition, very important and useful are the basic knowledge of formulation processes and some aspects about the methods of characterization of dosage forms are needed. Useful is also a basic knowledge of the conventional and innovative dosage forms. This knowledge is important for the multidisciplinary nature of the course and to the understanding of technologies applied to industrial production processes. Some of these basic aspects will be anyhow highlighted at the beginning of the course.

Study modes

In accordance with the instructions of the University, reported at https://www.uniroma1.it/it/notizia/covid-19-fase-3-lezioni-esami-e-lauree-presenza-e-distanza, the lectures of the courses of all study courses (first degrees, master's degrees, doctoral courses, masters) are in presence, to the extent of 100% of the places originally usable for each classroom , also guaranteeing remote use to allow the participation of those who cannot secure a place in the classroom and / or for health reasons will not be able to participate in face-to-face activities. The students will be divided in small groups and then it will be requested to apply, according to a more practical approach, the information acquired during the first part of the lesson. The lessons, that will be carried out “in presence”, will be supplemented with further explanations and checks following an applicative point of view. For a deeper insight, experts in the specific fields faced during the lessons will be invited.

Frequency modes

Non mandatory attendance

Exam modes

It will be proposed to the students (individually or in group) to develop a research which, taking into account the topics faced during the course, includes the various aspects related to the production and control of medicines, including the legislative point of view. If needed, a written paper will also be requested ( open answers).
A minimum score of 18/30 is needed to pass this exam.
As far as the overall evaluation of the exam is concerned, the final score will take into consideration how much the students are acquainted with the topics faced during the course, the logical evolution of the presentation of the proposed project as well as the skill and competences that were acquired. The use of appropriate terminology during the presentation will also play an important role.
Together with a check of the acquisition by the student of most aspects of the project proposed for the exam, it will be evaluated how wide and deep he/she is capable of discussing appropriately and logically the specific topic and to identify the noteworthy points of the problem that is faced.

Exam reservation date start	Exam reservation date end	Exam date
29/04/2022	04/05/2022	09/05/2022
27/05/2022	05/06/2022	10/06/2022
11/06/2022	16/06/2022	20/06/2022
27/06/2022	04/07/2022	12/07/2022
25/08/2022	08/09/2022	14/09/2022
21/09/2022	26/09/2022	29/09/2022
03/11/2022	13/11/2022	22/11/2022
24/10/2022	20/01/2023	25/01/2023