QbD理念下的英文缩写汇总
产品质量概况QTPP：Quality Target Product Profile
质量源于设计QbD：Quality by Design
关键工艺参数CPP：Critical Process Parameter
关键质量属性CQA ：Critical Quality Attribute
关键物料属性CMA：Critical Material Attributes
注册起始原料RSM：Registered Starting Material
风险评估RA：Risk Asssment
风险控制RC：Control Strategy
正常操作范围NOR：Normal Operating Range
证明可接受的范围PAR：Proven Acceptable Range
设计空间DSp：Design space
原料药：API Active Pharmaceutic Ingrediental Ingredient）或者Drug substance
制剂：Finished drug 或者Drug product
