Qb-ReDesign (Qb-R)

Quality by Re-Design (QbR) is a retrospective approach in applying the principles of QbD to the present lifecycle of existing pharmaceutical products that require continuous improvement and still using antiquated manufacturing processes. TetraGenx’s experienced team experts offer a cost-effective QbR approach by issuing a Risk Assessment on the impact of the pre-existing critical process parameters and material attributes affecting the drug product critical quality attributes. Gap analyses are carried out to understand the manufacturing processes and to identify the key steps for obtaining and assuring a pre-defined quality drug product.