Study of CPP
* Study of QTPP and CQA with FMEA method, and confirm the PAR, NOR and CPP of production process. Complete the quality risk study of each GMP step before process validation.
* In practical research, in order to improve efficiency, the processes with high complexity are handled with DoE strategy by statistical analysis software, while the ones with low complexity are handled with OVAT strategy.

Study of RSM
* RSM determination are proposed based on ICH guideline and requirements of drug administration in different countries.
* Proper RSMs proposals are determined based on the property of compounds, stability of supply chain, structure complexity.
* Impurities in RSMs are studied systematically, such as analogues, precursors, solvents and metal ions, in order to establish the proper specifications and determine the proper impurity control strategies.