Technology

Establishment of robust manufacturing process using QbD approach

API process control based on ICH’s Q11 requires the process understanding in deep, by QbD approach as follows;

(1) selection of API’s critical quality attributes (CQAs) and risk assessment (FMEA), (2) extraction of PCPPs (Potential Critical Process Parameters) and evaluation by multi-dimensional experiment such as quality engineering and design of experiment (DoE) (3) identification of CPPs (Critical Process Parameters). The process optimization through the QbD approach provides a robust manufacturing process with focusing on the commercial application including responses to the inquiries from health authorities.