Alessandro Regola is the AFI vice president in Milan and coordinator of the AFI Quality Section, and serves as pharmaceutical consultant in quality systems.

Alessandro Regola

Knowledge management has always been a key factor for the successful development and manufacture of pharmaceutical products. Understanding the chemical and physical processes underlying material interactions in dosage forms formulation, production processes, and product storage along its shelf-life is fundamental in assuring quality, efficacy, and safety of medicinal products. Knowledge has always directed the design of dosage forms (e.g., in terms of selection of excipients and primary packaging materials) and the development of production processes (e.g., in terms of process technology applied and process controls implemented).

Knowledge is normally assumed to be a combination of education and experience. Advanced education on chemistry, physics, microbiology, biology, analytics, materials properties, process technology, pharmacokinetics, pharmacology, toxicology, and physiology must be available in the pharmaceutical industry. Nowadays this ‘traditional’ form of education has to be integrated with a decent knowledge of information technology, data management, and processing. In addition, highly innovative and specialized areas, like biotech or advanced therapy, require specific knowledge of biochemistry, genomics, and cell engineering.

Pharmaceutical Technology’s October 2021 APIs, Excipients, and Manufacturing eBook

Pharmaceutical Knowledge Management: Experiences in Drug Development and Manufacturing

Pharmaceutical Technology’s APIs, Excipients, and Manufacturing 

Alessandro Regola,* a.regola@libero.it, is the AFI vice president in Milan and coordinator of the AFI Quality Section, and Marco Adami is an AFI member in Milan and coordinator of the Validation Group within the AFI Quality Section. They both serve as pharmaceutical consultants in quality systems and research and development, respectively.
*To whom all correspondence should be sent.

When referring to this article, please cite it as M. Adami and A. Regola, “Pharmaceutical Knowledge Management: Experiences in Drug Development and Manufacturing,” 

Pharmaceutical Technology’s APIs, Excipients, and Manufacturing

Articles

Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years