Quality By Design In Research And Development For Single Dose Small Molecule Lyophilized Dosage Form Generic Products

Objective: QbD(Quality By Design)is an essential part of c GMP,and it is a scientific,comprehensive and proactive drug development method based on risk.From product concept to industrialization are carefully designed,and should be well understanding the relationship between the product properties,production technology and product performance.This article using QbD concept to design in research and development for single dose small molecule lyophilized dosage form generic products,and set up reasonable robust control strategy,then can continue to guarantee/improve the quality of the products.That is the products and process reasonable life cycle.Methods:(1)Prospectively established quality target product profile(QTPP),begin as end,selected critical quality attributes(CQAs),then give the proposed generic product clear reasonable development targets.This study focused on those CQAs including assay and impurity.(2)A risk assessment of process variables was performed to evaluate the impact that each attribute could have on the single dose small molecule lyophilized dosage form generic products scientifically,then identify the high risk,determine the scope of the study,and find out the key step in the development process is compounding,filtering,filling,freeze-drying process,then define the design space with CQAs for each process parameter,and then a control strategy was proposed to reduce the risks also can provide guarantee for the quality of the product.(3)Pilot batch was studied.Conclusion: When the formulation and process were finalized,it can continue to guarantee/improve the quality of the products.The outcome of the study shown QbD methodology is useful to get highly efficient and flexible production and produce high quality drug product consistently.That is the products and process reasonable life cycle.