B016442 - TECHNIQUES AND IMPLANTATIONS OF PHARMACEUTICAL PRODUCTION

Italian

Structure and organization of the Pharmaceutical Industry. GMP and process validation. Centralized technical services. Sewage disposal and emission treatment. Working areas. Materials for pharmaceutical use. Water for pharmaceutical use. Sterilization. Lyophilization. Pulverization, mixing, granulation, drying, pelletization methods. Preparation and distribution of solid dosage forms, liquid forms, liquid-solid forms, pressurized forms. Production lines. Packaging and storage.

1) L. Fabris, A. Rigamonti "La fabbricazione industriale dei medicinali" Soc. Ed. Esculapio (Bo)
2) M.E. Aulton, K. M.G. Taylor, "Tecnologie Farmaceutiche – progettazione a allestimento dei medicinali", Edra Ed
3) P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale "Principi di tecnologia farmaceutica", Casa Editrice Ambrosiana

The course proposes to provide an insight of the main aspects involved in pharmaceutical production according to GMP (Good Manufacturing Practices) standards, from the premises in the industry to the business organization, with their related figures of responsibility. Furthermore, particular attention is paid to the development phases of a drug, formulation aspects, description of the equipment, operations and materials most used in the production process and to the quality control.
There are also present moments of confrontation with pharmaceutical industry professionals, in order to make the students aware of the practical application, the usefulness and the multidisciplinary nature of the knowledge acquired during the course, and to inform them of both the hard and soft skills most requested by companies for integration into the labour market.

As by study plan

Frontal teaching lessons and exercises (i.e. videos regarding the production of pharmaceutical dosage forms). To supplement the official course, specialized seminars could be held by highly qualified professionals in the pharmaceutical field to supply the appropriate scientific training to operate in the industrial field.
Teaching material: All the lessons can be downloaded from the new e-Learning Moodle platform (http://e-l.unifi.it/). The password is given at the first lesson of the course. This material, supplemented by the notes taken directly during the lessons, is fully sufficient for the preparation of the exam. However, some recommended texts to focus on specific topics are given at the first lesson of the course.
Teaching tools: video projection of slides, PDF files

Receiving students: Every day, by appointment
Ex Dipartimento di Scienze Farmaceutiche, Via U. Schiff 6
50019 Sesto F.no (FI)

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.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. Each question is given a score as follows:
A) Closed questions:
Correct answer: 2 points
Wrong answer: zero points
B) Open questions
2 questions on a scale of 0 to 5
2 questions on a scale of 0 to 5
1 question associated with an image on a scale of 0 to 4

The score will be awarded according to the correctness of the theoretical concepts, appropriateness and comprehensiveness of the answer, language and synthesis properties, clear presentation, ability to operate comparisons and connections.

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.