RICHMOND, Va.--(BUSINESS WIRE)--Phlow Corp., a public benefit essential medicines solutions provider, and the United States Pharmacopeia (USP) today announced a strategic alliance to develop a new ...
Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support ...
Collaboration and new tools aid efforts to implement new processing technologies for small-molecule drug product manufacturing. Pharmaceutical manufacturing is inching towards implementing more ...
Healthcare is embracing continuous validation to enhance system reliability, moving beyond traditional testing. Shift-Left and Shift-Right practices, augmented by GenAI and observability tools, ensure ...
In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...
Dr. Siva Samy is the founder and CEO of ValGenesis, an inventor with 8 patents in digital and AI-based validation, and a Ph.D in Pharma. For decades, validation in life sciences has been treated as a ...
Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...