This is part two of a five-part piece. Part one can be found here.
The Scientific-Based Quality Driver
Underpinning all of AMRI’s development and manufacturing work is the company’s pharmaceutical and quality services (PQS) group. PQS provides an essential foundation for the company’s product development processes as it is within this group that critical support is provided as the manufacturing process is being developed, optimized and set in place.
PQS supports the company’s efforts with a wide range of pharmaceutical development, quality assurance and regulatory affairs services including:
- Analytical development and separation sciences.
- Spectroscopy services.
- Pre-formulation and materials science.
- Formulation development.
- Quality assurance and regulatory affairs services.
This department within the company is also somewhat unique as it operates differently when compared to similar groups in other companies. At AMRI, a developmental scientist is assigned to the product and helps shepherd it through testing, pilot plant and into manufacturing. This elimination of “silos” ensures a smooth transition from one phase to the next.
“At AMRI our scientists don’t work in isolation,” says Junan Guo, Ph.D., Vice President, Pharmaceutical and Quality Services, “they work integrally with other groups within the company to offer an integrated approach. They offer continuous support through the drug’s development lifecycle.”
Please tune into tomorrow’s Chemical Equipment Daily for part three of this five-part series. To read part one of this four-part series, please click here.