ABSTRACT
OBJECTIVE: To prepare parecoxib sodium freeze-dried preparation, evaluate and validate the feasibility of the production process and quality reliability of the preparation. METHODS: Risk assessment of the production process of parecoxib sodium freeze-dried preparation was performed based on the method of quality by design (QbD).The key steps and key process parameters were identified.The critical quality attributes (CQAs)of the intermediates and final product were clarified, the validation protocol and acceptable standard were accordingly developed, and the production process was validated. RESULTS: The production process of parecoxib sodium freeze-dried preparation met the GMP requirements, and the intermediate and final products met the quality standards. CONCLUSION: The established production process of parecoxib sodium freeze-dried preparation is feasible and the product quality is controllable.