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Drug Approval, Pharmacology / 04.12.2024

quality-by-design in biopharmaceutical development The biopharmaceutical industry has undergone significant transformations in recent years, particularly with the adoption of Quality by Design (QbD) principles. This innovative approach is reshaping the landscape of biopharmaceutical manufacturing by fostering a culture of quality that prioritises proactive measures over reactive solutions. This transformation not only enhances the efficiency of manufacturing processes but also ensures that patients receive safe and effective medications.

What is Quality by Design (QbD)?

Quality by Design is a strategic framework introduced to ensure that quality is built into pharmaceutical products from the outset, rather than being tested in at the end of the manufacturing process. This concept emerged from the need for a more scientific and risk-based approach to drug development, particularly in light of the complexities inherent in biopharmaceutical manufacturing. QbD is built upon several core elements, including:
  • Quality Target Product Profile (QTPP): This outlines the desired characteristics of the final product, including its intended use, dosage form, and delivery method.
  • Critical Quality Attributes (CQAs): These are the physical, chemical, and biological properties that must be controlled to ensure the product meets its QTPP.
  • Critical Process Parameters (CPPs): These are the variables that influence the CQAs during manufacturing and must be monitored to maintain product quality.
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Education, Nursing / 12.07.2024

Nurse leaders play a pivotal role in the healthcare industry, orchestrating both clinical and administrative functions to ensure optimal patient care and organizational efficiency. Their leadership impacts various aspects of healthcare delivery, from patient care standards to team dynamics and policy implementation. In this blog, we will share how nurse leaders are not just part of the healthcare system but vital drivers of its evolution and efficiency.

Visionary Leadership and Strategic Planning

Nurse leaders exemplify visionary leadership that is crucial in steering healthcare organizations towards success. By developing and implementing strategic plans, they address both current and future healthcare demands. These leaders are adept at identifying trends in healthcare, foreseeing potential challenges, and crafting strategies that promote sustainability and growth. Their strategic initiatives might include expanding services, improving patient care models, or integrating cutting-edge technologies. The ability of nurse leaders to think strategically ensures that healthcare organizations are well-prepared to deliver high-quality care in a constantly changing environment. (more…)