B016442 - TECHNIQUES AND IMPLANTATIONS OF PHARMACEUTICAL PRODUCTION

Italian

The medicine supply chain from research to marketing. Good Manufacturing Practices. Quality assurance and control. Structure and organization of the pharmaceutical industry. Centralized technical services. FU XI. Water for pharmaceutical use. Sterilization and lyophilization. Milling, mixing, granulation, and drying methods. Characteristics, manufacturing, and packaging of solid, liquid, liquid-solid, and pressurized dosage forms. Pharmaceutical manufacturing equipment and production lines.

1) Slides made available by the teacher in PDF format
2) Official Italian Pharmacopoeia
3) Good Manufacturing Practice (GMP) guidelines
4) L. Fabris, A. Rigamonti "La fabbricazione industriale dei medicinali" Soc. Ed. Esculapio (Bo)
5) M.E. Aulton, K. M.G. Taylor, "Tecnologie Farmaceutiche – progettazione a allestimento dei medicinali", Edra Ed 6) P. Colombo, F. Alhaique, C.
6) Caramella, B. Conti, A. Gazzaniga, E. Vidale "Principi di tecnologia farmaceutica", Casa Editrice Ambrosiana

KNOWLEDGE AND UNDERSTANDING

Knowledge related to:
1) development of medicinal products and their marketing;
2) Good Manufacturing Practices;
3) structure of the pharmaceutical industry, with particular emphasis on the quality system (quality assurance and quality control);
4) structure and contents of the Italian Official Pharmacopoeia;
5) characteristics and properties of the pharmaceutical dosage forms;
6) production and packaging processes of medicines;
7) pharmaceutical manufacturing equipments and problems related to their operation.

ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING

Abilities to:
1) understand the problems associated with the development of drugs and their marketing;
2) understand the requirements of efficacy, safety, and quality at the basis of the Good Manufacturing Practices for medicinal products;
3) identify the role and responsibilities of pharmaceutical industry professionals;
4) identify the tests necessary for the assessment of compliance with the quality requirements of the various pharmaceutical forms;
5) use the terminology of the pharmaceutical industry;
6) evaluate the advantages and limitations of various pharmaceutical dosage forms;
7) identify the production problems of the different pharmaceutical formulations and propose possible solutions;
8) deepen the topics and regulations of the sector;
9) connect and identify points in common between the topics discussed during the lectures.

Basic skills in maths, physics, general chemistry and organic chemistry.

The course is organized into frontal teaching lessons (64 hours) and classroom exercises (12 hours). The exercises (videos and images projection, reading of scientific articles, provision of interactive quizzes, and simulation of business problems) will allow the student to develop problem solving, connection, and communication skills. The course can also be integrated with speeches by professionals from the pharmaceutical industry in order to show the student the practical application, usefulness, and multidisciplinarity of the knowledge acquired and to make him aware of the skills (hard and soft) required by pharmaceutical companies for entering the world of work.

Teaching materials:
Pdf files of the lessons that can be downloaded from the Moodle e-Learning platform
Lecture notes
This material is sufficient for the preparation of the exam. In addition, some textbooks are suggested for students interested in deepening specific topics (see the session suggested readings).

Teaching tools:
video projector, PC, e-learning platform Moodle

Receiving students:
Every day, by appointment

Address:
Ex Dipartimento di Scienze Farmaceutiche, Via U. Schiff 6
50019 Sesto F.no Firenze
Tel. 055 4573710
e-mail: natascia.mennini@unifi.it

6 official examination calls are scheduled: 2 in the winter session (January-February) and 4 in the summer session (June-September). In addition, there are 2 examination calls, one in November and one in April, during periods of teaching silence and 2 extraordinary examination calls for graduating students. The final exam consists of a written test lasting 120 minutes with a mixed structure (open-ended questions and multiple-choice questions) covering the whole program carried out. Each question is given a score as follows:

Closed questions:
Correct answer: 2 points
Wrong answer: zero points

Open questions
2 questions on a scale of 0 to 5 points
2 questions on a scale of 0 to 3 points
1 question associated with an image on a scale of 0 to 4 points

The score of the open questions will be assigned according to:
Appropriateness of the answer and correctness of the concept exposed: 40%
Completeness of the answer: 30%
Clarity of exposition, language and synthesis properties: 20%
Ability to make comparisons and connections: 10%

Closed-ended and open-ended questions contribute respectively for 37.5% and 62.5 to the determination of the final grade.
The exam is considered passed if a mark greater than or equal to 18 is achieved.

Structure and organization of the Pharmaceutical Industry.
The drug discovery process
Good Laboratory Practices (GLP) e Good Clinical Practices (GCP): Basic Principles
Good Manufacturing Practices (GMP): Basic Principles. Quality Management: Quality Management; Quality Assurance (QA); GMP; Quality Control (QC).Qualified Person. Staff. Documentation. GMP in Production. Contamination and cross-contamination.
Process validation. Utilities for the production of Steam, Gas, Compressed Air, Vacuum, Cold, Electric Power.
Sewage disposal and emission treatment. Working areas.
Materials for pharmaceutical use.
Water for pharmaceutical use. Preliminary and purification methods.
The Italian Pharmacopoeia: general concepts
Sterilization. Freeze drying.
Preparation of solid pharmaceutical forms. Pulverization, mixing, dry and wet granulation, drying methods. Tablets Production and Tablet coating. Production of hard and soft capsules. Preparation and packaging of liquid pharmaceutical forms. Vial production lines. Pre-filled syringes. Preparation and packaging of fluid-solid pharmaceutical forms: creams and suppositories. Preparation of pressurized pharmaceutical forms.
Primary and secondary packaging: general. Official containers. Illustrative leaflet. Packaging materials. Production lines, primary and secondary packaging lines for solid, liquid and fluid-solid pharmaceutical forms. Controls in process. Storage.

The course is in line with the objectives:
Health and Wellness
Industry, Innovation and Infrastructure