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 ...

The pharmaceutical and biopharmaceutical industries are currently underutilizing their manufacturing data, with a significant portion of the collected data either non-actionable or of insufficient ...

In 2011, the FDA outlined the potential benefits of continued process verification, suggesting drug companies could use analytical technologies and process data to assess production processes in real ...

Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...

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 ...

Validating drug production processes need not be a headache, according to AI researchers, who say machine learning could be a single answer to biopharma’s multivariate problem. The FDA defines process ...