Ajay Pazhayattil

Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.

A data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

Flexible batch sizes for semi-continuous unit operations, such as tableting and encapsulation, can improve efficiency while maintaining quality.