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
4) M. Amorosa, “Principi di tecnica farmaceutica”, Piccin
Learning Objectives
KNOWLEDGE AND COMPREHENSION:
• knowledge of the specific terminology of the pharmaceutical industry
• basic knowledge on the organization of the Pharmaceutical Industry;
• knowledge of the legislation regarding the industrial pharmaceutical manufacturing
• knowledge of the chemical-physical principles applied to the various pharmaceutical manufacturing processes;
• overview of the modern industrial systems for the production and packaging of various pharmaceutical forms and related issues;
• basis knowledge for problem solving, highlighting the multidisciplinarity of the topics
ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING:
• Ability to use the industrial terminology appropriately
• Reasoning skills
• Connecting skills towards the various covered topics
• Problem-solving skills
Prerequisites
As by study plan
Teaching Methods
Frontal teaching lessons and exercises (i.e. videos regarding the production of pharmaceutical dosage forms, quiz and questionnaires). 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
Further information
Receiving students: Every day, by appointment
Ex Dipartimento di Scienze Farmaceutiche, Via U. Schiff 6
50019 Sesto F.no (FI)
Type of Assessment
7 official examination calls are scheduled: 3 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 1 extraordinary examination call. 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 regarding the organization of the pharmaceutical industry and the reference standards in the EU is primarily assessed. Once this phase is successfully passed, the examination can continue with the assessment of the knowledge on 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.
The following parameters will also contribute to the determination of the final mark: the ability to apply knowledge and understanding through parameters such as reasoning and connection skills between the various topics covered, as well as problem-solving skills, in addition to the quality of the exposition and the use of an appropriate terminology.
Course program
Structure and organization of the Pharmaceutical Industry. Good Manufacturing Practices (GMP): Basic Principles. Quality Management; Quality Assurance (QA); Quality Control (QC). Qualified Person (QP). Staff. Documentation. Contamination and cross-contamination. Complaints and recall. 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. MDI, DPI, nebulizers.
Primary and secondary packaging: general. FU containers. Package leaflet. Packaging materials. Production lines, primary and secondary packaging lines for solid, liquid and fluid-solid pharmaceutical forms. Controls in process. Storage.