Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

ValGenesis Smart GxP™ is the first AI-enabled platform purpose-built to unify validation and process development across the product lifecycle. Featuring five integrated applications—ValGenesis iCMC™, ...

ValGenesis Inc., the global leader in digital validation lifecycle management, will exhibit its Smart GxP™ platform at the ...

ValGenesis Inc., the global leader in digital validation lifecycle management, will showcase its AI-enabled Smart GxP™ ...

European Medicines Agency (EMA) which has been following the US FDA guidelines on Process validation so long, has now revised the process validation norms. The revision incorporates the principles of ...

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 ...

This article proposes an independent structured review process for legacy products—those pharmaceuticals that predate FDA’s updated process validation and quality by design [QbD] guidance. This ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

IBC's 13th International Process Validation for Biopharmaceuticals answers the question: What else can I gain out of my process validation activities and how do I perform them most effectively? In ...

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...