Process development is the exercise of creating new and improved manufacturing methods, optimizing them in terms of time and financial efficiency while maintaining regulatory compliance and product ...

In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, ...

Raw material verification is slowing pharmaceutical production, but mass spectrometry can offer a viable solution.

As industry shifts to continuous biomanufacturing, engineers integrate process design, digital tools, automation, and ...

Batch remains advantageous for development, variable demand, and bounded risk, benefiting from natural hold points, simpler investigations, and lower upfront capital, despite longer lead times and ...

The compliance process at pharmaceutical manufacturers is complicated because many still use paper-based systems to record manufacturing steps. These paper records are reviewed by FDA auditors to ...

Procurement frameworks now incorporate resilience criteria, enabling tender preference for diversified, Europe-based manufacturing and contingency capacity over lowest price, reshaping economics for ...