Validation by design thinking in the pharmaceutical industry, often referred to as “Validation 4.0”, is a shift in approach that adapts to the evolution of the industry.
RABS are a type of barrier system that separates the production area from the operator environment by using a rigid machine enclosure, safety-locked doors and ports with gloves.
The field of biomanufacturing is undergoing a remarkable transformation with the integration of Artificial Intelligence (AI) technologies. AI, a domain of computer science that aims to create machines capable of intelligent behavior, is revolutionizing the way biopharmaceuticals and other bioproducts are developed, manufactured, and refined.
Keeping health products safe means ensuring that the product lifecycle are implemented and in control. The health product lifecycle here refers to all stages in the pre- and post-market “life” of a health product. According to Health Canada, the stages may include several or all of the following: pre-clinical studies, clinical trials, submission of product