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QbD Study

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QbD Study

Study of CPP

Study of QTPP and CQA with the FMEA method, and confirm the PAR, NOR, and CPP of the production process. Complete the quality risk study of each GMP step before process validation.

In practical research, to improve efficiency, the processes with high complexity are handled with the DoE strategy by statistical analysis software, while the ones with low complexity are handled with the OVAT strategy.

Study of RSM

RSM determinations are proposed based on ICH guidelines and requirements of drug administration in different countries.

Proper RSM proposals are determined based on the properties of compounds, stability of the supply chain, and structure complexity.

Impurities in RSMs are studied systematically, such as analogs, precursors, solvents, and metal ions, to establish the proper specifications and determine the proper impurity control strategies.