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, ...

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 ...

Advances in data science and digitalization are transforming the world, and the pharmaceutical industry is no exception. Multiple sensor-equipped manufacturing processes and laboratory analysis are ...

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 ...

Containment is defined as the isolation of substances from the operator, from the environment and from other substances. Containment systems have to manage emissions and exposure, both generated by ...