Pharmaceutical Technology - October 2021


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58 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m Quality K nowledge management has always been a key factor for the successful development and manufacture of pharmaceu- tical 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 prod- ucts. 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, biol- ogy, analytics, materials properties, process technology, pharmacokinetics, pharmacology, toxicology, and physiology must be available in the phar- maceutical 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 special- ized areas, like biotech or advanced therapy, require specific knowledge of biochemistry, genomics, and cell engineering. To be successful in the pharmaceutical industry, scientific knowledge must be supported by skills in other areas such as project management, risk analysis, budgeting and cost controlling, and regulatory affairs. Given the large and different number of fields of knowledge required to develop and manufacture medicinal products, it goes without say- Pharmaceutical Knowledge Management: Experiences in Drug Development and Manufacturing Marco Adami and Alessandro Regola Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years Alessandro Regola,*, 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 addressed. WRIGHTSTUDIO - STOCK.ADOBE.COM

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