Continued process verification (CPV) is the third stage of the product lifecycle of any medicine either within the small or large molecule arena. The CPV is the subsequent step to process design ...
It’s a wonder that any electronic system works as intended, or that it continues to work months or years after it is sold. The reason: SoCs have become so complex that no verification coverage model ...
SAN FRANCISCO--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in ...
This article overviews some of the benefits and methods of state-based control as it applies to the models defined by the ISA106, Procedure Automation for Continuous Process Operations standards ...
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 ...
As part of current good manufacturing practice (cGMP), many pharmaceutical manufacturers are adopting Process Analytical Technologies (PAT), Quality by Design (QbD), or Process Validation (PV) to ...
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 ...
Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...
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