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 ...

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 ...

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which ...

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 ...

The European Medicines Agency (EMA) has released a new draft guideline on process validation that brings EMA thinking in line with the International Conference on Harmonization of Technical ...