THREE-DIMENSIONAL MODELING

Course objectives

General expected learning outcomes The Industrial Manufacturing of Medicines course aims to provide the knowledge related to the marketing procedure (AIC), to the industrial plant engineering, to the production processes of drugs, to the Good Manufacturing Practice (GMP) and Standards. At the same time the students will acquire the competences of the pharmaceutical technologies used in the industrial production and packaging of medicines. The course will also allow the students to be informed about the regulations that are needed, and later applied, for an appropriate planning and validation for the industrial production of medicines. During specific moments of discussion and deeper insight the students will have the opportunity to contact people that exert their professional activity in pharmaceutical companies. Industrial Manufacturing of Medicines is an interdisciplinary course that has an applicative approach which will allow, after the final degree (laurea specialistica), to enter the working world because he/she will be able to face, analyze and evaluate the various problems related to the industrial processes that are needed for medicine marketing. Specific expected learning outcomes 1. Knowledge and understanding Regulation, technologies, processes, and plant engineering knowledge required to operate with high qualification in the manufacturing industry of traditional, innovative, and biotechnological medicines will be acquired. 2. Applying knowledge and understanding At the end of the course the student will be able to apply the information given during the lectures that will face the specific topics related to the chemical-pharmaceutical industry, both from a technical point of view as well as in accordance with current regulations. The student will be able to follow the various phases of drug production for the different dosage forms. At the same time, the acquired preparation, will allow him/her to face all the steps and problems related to formulation, regulation, safety, and validation. 3. Making judgements The “classical” lectures will include discussion and assessment method moments, together with programmed interactions with people directly involved in pharmaceutical companies, will allow the students to organize and follow a specific project. Taking into consideration one of the topics that were faced during the course they will be able to write (singularly or as a team) a report that can demonstrate their autonomous ability to evaluate the technological, regulatory and safety issues related to the manufacturing of the various dosage forms. 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. For a deeper insight, experts in the specific fields faced during the lessons will be invited. 4. Communication skills During the course, several moments will be devoted to debates, discussions, and roundtables under the professor’s supervision; in this sense specific selected topics will be assigned to the students. This activity, that will be carried out both individually and as small groups, will allow to evaluate the communication skills of the students with respect to the acquired information. These sessions will be important to develop the ability to critically evaluate technological, regulatory and safety issues related to the manufacturing of the various dosage forms. In these occasions the students will also develop their ability to properly report on the selected topics in front of the professor and their colleagues (peer assessment). 5. Learning skills Both theoretical and practical information that will be given during the course is also intended to develop the personal ability of an autonomous and independent learning (continuous education). This will allow the students to critically evaluate the medicine production and validation processes, and to appropriately understand, and correctly apply, the current regulations. Furthermore, the preparation acquired during the course will allow the students to keep his/her information and skills always updated in the field of industrial pharmaceutical production: a world which is in continuous and rapid evolution.

Channel 1
FEDERICA RINALDI Lecturers' profile

Program - Frequency - Exams

Course program
Part 1 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 AIFA-EMA 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 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 Preparation of solid dosage forms Preparation of liquid dosage forms Preparation of semi-solid dosage forms. Packaging Part 4 OUTLINES AND PRACTICAL ASPECTS RELATED TO NON-CONVENTIONAL DOSAGE FORMS: SCALE UP, CROSS CONTAMINATION, HANDLING, STAFF
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.
Books
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)
Teaching mode
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 held primarily in the presence, to the extent of 100% of the places originally usable for each classroom and taking into account safety distances, 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. During the lessons, moments of explanations by the teacher will alternate with moments of comparison and learning tests.
Frequency
Non mandatory attendance
Exam mode
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. 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. Specifically, the evaluation rubric is structured as follows: Failing: Insufficient and fragmented knowledge; poor analytical and synthesis skills; inappropriate generalizations; inadequate or absent use of technical language. 18–20/30: Minimal and not fully consolidated knowledge; weak analytical and synthesis skills; limited ability to use technical terminology. 21–23/30: Sufficient understanding of the topics; coherent but not in-depth argumentation; acceptable use of technical language. 24–26/30: Good level of understanding; well-developed analytical and synthesis skills; clear presentation with appropriate use of technical language. 27–29/30: Solid preparation; rigorous and consistent argumentation; strong command of technical and regulatory terminology. 30–30 with honors: Excellent mastery of content; high-level critical thinking and synthesis; precise, original, and innovative presentation; flawless use of technical language.
Bibliography
Updated scientific articles provided by the teacher
Lesson mode
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.
FEDERICA RINALDI Lecturers' profile

Program - Frequency - Exams

Course program
Part 1 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 AIFA-EMA 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 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 Preparation of solid dosage forms Preparation of liquid dosage forms Preparation of semi-solid dosage forms. Packaging Part 4 OUTLINES AND PRACTICAL ASPECTS RELATED TO NON-CONVENTIONAL DOSAGE FORMS: SCALE UP, CROSS CONTAMINATION, HANDLING, STAFF
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.
Books
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)
Teaching mode
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 held primarily in the presence, to the extent of 100% of the places originally usable for each classroom and taking into account safety distances, 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. During the lessons, moments of explanations by the teacher will alternate with moments of comparison and learning tests.
Frequency
Non mandatory attendance
Exam mode
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. 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. Specifically, the evaluation rubric is structured as follows: Failing: Insufficient and fragmented knowledge; poor analytical and synthesis skills; inappropriate generalizations; inadequate or absent use of technical language. 18–20/30: Minimal and not fully consolidated knowledge; weak analytical and synthesis skills; limited ability to use technical terminology. 21–23/30: Sufficient understanding of the topics; coherent but not in-depth argumentation; acceptable use of technical language. 24–26/30: Good level of understanding; well-developed analytical and synthesis skills; clear presentation with appropriate use of technical language. 27–29/30: Solid preparation; rigorous and consistent argumentation; strong command of technical and regulatory terminology. 30–30 with honors: Excellent mastery of content; high-level critical thinking and synthesis; precise, original, and innovative presentation; flawless use of technical language.
Bibliography
Updated scientific articles provided by the teacher
Lesson mode
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.
  • Academic year2025/2026
  • CourseIndustrial pharmacy
  • CurriculumSingle curriculum
  • Year4th year
  • Semester2nd semester
  • SSDCHIM/09
  • CFU6