Quality Measures

Manufacturing complex pharmaceutical products with new technologies

March 11, 2024 - Scientific advancement and increasingly complex pharmaceutical products have reshaped the healthcare industry, providing novel tools and solutions for managing broad conditions, from acute viral infections to chronic diseases to oncology. As science evolves, developing increasingly complex pharmaceutical products, manufacturers and biopharmaceutical companies must evolve their...


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Developing Quality Assurance Standards for Biologics, Biosimilars

by Veronica Salib

Biologics and biosimilars are a rapidly growing sector of the biopharmaceutical industry. However, as the field grows, multiple challenges arise in the manufacturing and quality assurance guidelines for biologics and...

Advancing Sterility Assurance Through Environmental Monitoring

by Alivia Kaylor

In the pharmaceutical industry, ensuring the safety and efficacy of drugs is of utmost importance. Quality assurance is critical in maintaining high standards for pharmaceutical products, and one essential aspect of quality assurance is...

Navigating the Complex Terrain of Influenza Vaccine Strain Selection

by Alivia Kaylor

In the battle against influenza, the annual selection of vaccine strains is a crucial step in ensuring the effectiveness of flu vaccines. The process involves an intricate dance of global surveillance, scientific analysis, and regulatory...

How Quality Assurance Shapes US Drug Manufacturing

by Alivia Kaylor

The world of pharmaceuticals stands as a cornerstone of modern medicine. Behind every pill, every capsule, and every syringe lies an intricate process of creation, where precision and excellence are non-negotiable. Drug manufacturing is a...

FDA Announces That 35% of Drug Samples Were Non-Compliant

by Veronica Salib

The FDA’s Report on The State of Pharmaceutical Quality is published annually to analyze quality measures related to drug manufacturers and products. The report looked at manufacturing site...

Nephron Pharmaceuticals Recalls 2.1 Million Doses of Medicine, Medical Equipment

by Alivia Kaylor

According to the FDA’s enforcement report, Nephron Sterile Compounding Center, in Columbia, South Carolina, is recalling 2,158,351 medical products including syringes and bags because of a lack...