B012277 - IMPLANTATIONS OF PHARMACEUTICAL INDUSTRY

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.

L. Fabris, A. Rigamonti “La fabbricazione industriale dei medicinali” Soc. Ed. Esculapio (Bo)

The course provides a basic knowledge on the organization of the Pharmaceutical Industry;
introduces the chemical-physical principles applied to the various pharmaceutical manufacturing processes; provides an overview of the modern industrial systems for the production and packaging of various pharmaceutical forms and related issues; provides the basis for problem solving, highlighting the multidisciplinarity of the topics.

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 and another 1-2 extraordinary appeals. It is mandatory to pass the examination of Technology, Socio-Economy and Pharmaceutical Legislation before this exam. The final exam consists of an oral exam lasting about 45-50 minutes covering the whole program.
The knowledge of the topics is assessed, regarding the organization of the pharmaceutical industry and the reference standards in the EU, the chemical-physical principles applied to the various production processes of the pharmaceutical industry, modern industrial plants connected to the production and packaging of various pharmaceutical forms, and related problems.
Understanding and skills are also assessed through parameters such as reasoning and connection skills between the various topics covered, together with the quality of the exposition and the use of an appropriate technical language, as well as problem-solving skills.

Structure and organization of the Pharmaceutical Industry. 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. Sterilization. Freeze drying. Preparation of solid pharmaceutical forms . Pulverization, mixing, dry and wet granulation, drying, pelletization 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.