B2844 - Industrial Manufacturing and Regulation of Medicines

Learning outcomes

At the end of the course the student - acquires basic knowledge relating to the organizational structure of the pharmaceutical industry in relation to the characteristics of the company; - has in-depth knowledge of the industrial processes for the production of sterile and non-sterile medicines; - will be able to critically address and overcome the various problems that arise in all phases of medicinal product manufacturing; - acquires fundamental notions relating to the regulatory aspects of the production and marketing of industrial medicines, such as GMP, European legislation for placing on the market and the main ICH guidelines; - correctly uses the technical and regulatory language relating to the industrial manufacturing of medicines.

Course contents

The course is structured into two modules.

Part 1 (prof. Beatrice Albertini ) (48h)

- Pharmaceutical industry:Origin, development, and organization of the pharmaceutical industry. Types of pharmaceutical manufacturing. Conventional medicines and biotechnological medicinal products. Industry 4.0. Time-to-market of a medicinal product. Generic medicines and biosimilars. Organizational structure of the pharmaceutical industry. Centralized technical services (utilities) and production facilities.

- Water for pharmaceutical use.

- Production of liquid dosage forms: stirrers, mixers, homogenizers, filters and integrity tests.

- Manufacturing of sterile liquid dosage forms: bottle washing, vial washing, and liquid filling operations. Terminal sterilization, sterilizing filtration, and aseptic processing, including the use of isolators and Restricted Access Barrier Systems (RABS). Environmental monitoring, disinfection procedures, and visual inspection (sorting).

Specific requirements of EU cGMP Annex 1, including contamination control strategies, processing and monitoring systems, and personnel requirements.

Advanced sterile manufacturing technologies, including pre-filled syringes and Blow-Fill-Seal (BFS) technology.

- Freeze-drying: theory and equipment and applications.

- Sterilization: theory and equipments for heat sterilization and gamma sterilization.

- Production of solid dosage forms: milling, sieving, mixing, wet and melt granulation, pellettization, drying, tableting, capsule filling, film coating and sugar coating.

- Production of aerosol and inhaler devices

- Manufacturing of semi-solid dosage forms: equipments, process variables.

- Transdermal patches: formulation and production

- Packaging

Part 2 (prof. Nadia Passerini) (16h)

- Structure and organization of the pharmaceutical industry.

- General overview of the European Union pharmaceutical legislation concerning medicinal products for human use; Good Manufacturing Practice; procedures for Marketing authorisation, the Common Technical Document.

- Stability studies: stability of a drug product; ICH/CPMP guidelines for stability tests (long-term, accelerated and stress studies).

- The concept of validation for the pharmaceutical industry.

- Technology Trasfer and Process Analytical technologies (PAT)

Readings/Bibliography

• La Fabbricazione Industriale dei Medicinali. L. Fabris, A. Rigamonti. Società Editrice Esculapio

• Tecnologia Farmaceutica. P. Caliceti, Casa Editrice Ambrosiana, Zanichelli, 2025.

 

 Annex 1 of cGMP

Teaching methods

The course is delivered through lectures.

For both modules, a number of lectures are delivered by professionals working in the pharmaceutical industry, providing students with direct exposure to current industrial practices and perspectives.

Attendance requirements are considered fulfilled upon participation in at least 60% of the lectures. Attendance is monitored through the University's student attendance tracking application.

Regular and active participation in the lectures of both modules is considered an important component of the learning process and strongly contributes to the achievement of the course learning outcomes.

Assessment methods

The examination is designed to assess whether students have acquired the knowledge and skills required to work professionally within the pharmaceutical industry.

Assessment is based solely on a final examination consisting of an oral discussion covering the content of both modules.

In particular, students are assessed on:

• Knowledge of the fundamental aspects of pharmaceutical formulation development and industrial manufacturing processes. For example, students may be asked to discuss the formulation and manufacturing characteristics of a marketed medicinal product, provided either in its primary or secondary packaging.
• Knowledge of European pharmaceutical legislation governing the manufacture, quality control, and marketing authorization of medicinal products.
• The ability to apply the above knowledge to identify, interpret, and address issues arising during the formulation development and industrial manufacturing of medicinal products.

The final course grade is calculated as the weighted average of the grades obtained in the two modules.

Teaching tools

Material: the material presented in class will be available to the student in electronic format through the web site: https://virtuale.unibo.it/

Office hours

See the website of Beatrice Albertini

See the website of Nadia Passerini