The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under 21 CFR 211.110 governing batch ...

In the food and beverage industry, color is far more than a visual aesthetic feature. It serves as a critical indicator ...

Process analytical technology in biomanufacturing has undergone a fundamental transformation over the past two decades, moving quality control from the analytical laboratory to the manufacturing floor ...

Historically, pharmaceutical products have been produced in a traditional ‘batch’ system, in which every operation is executed separately using a defined quantity of materials. In batch manufacturing ...