Advancing the implementation of innovative analytical technologies in pharmaceutical manufacturing-Some regulatory...

Analytical technologies and methods play a pivotal role in attribute understanding and control which are essential to the rapidly evolving field of pharmaceutical development and manufacturing. These technologies are advancing quickly, where innovations often involve both new scientific approaches and novel applications of established techniques. In many cases, the lack of harmonized global regulatory expectations presents challenges for the adoption of advanced technologies. This review explores some emerging technology trends and applications, while highlighting regulatory considerations for integrating innovative analytical approaches in pharmaceutical manufacturing. We provide detailed examples on the multi-attribute method (MAM), rapid microbial testing for environmental monitoring, and Raman spectroscopy for product identification, while discussing aspects of the current regulatory landscape and desired future advancements in the regulatory framework. We hope to promote the adoption and implementation of innovative analytical technologies for enhanced patient access, while ensuring product quality and safety.