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 ...

While many companies began implementing AI to empower their teams with insights and recommendations, AI is rapidly evolving to perform tasks autonomously without human intervention. With these new ...

The pharmaceutical industry stands at the precipice of a profound transformation, moving from traditional batch processing to the more efficient and agile paradigm of continuous manufacturing (CM).

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 ...

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 ...

In today’s Pharma 4.0 world, real-time oversight and digital traceability are critical, forcing manufacturers to reassess efficiencies while advancing quality control and confidence. Binder jet ...

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 ...

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 ...