3.关键工艺参数(Critical Process Parameter,CPP):指其波动会影响到产品关键质量属性而应该被监测或控制的工艺参数,以确保能生产出预期质量的产品。 4.关键物料属性CMA:为达到目标产品质量,物料的物理、化学和生物学性质必须限定和控制在一定范围内,或在一定范围内分布。 二、关键工艺参数评定 药品生产依附于物料、生...
So theQTPP for A-Vaxbecomes: In the next article, I’ll write further on how A-VAX co-authors attempted to connect QTPP to CQA’s and CPP’s or CMA’s. While the effort was appreciated, the approach seemed disjointed and complex mainly because of the process-silo’ing approach. Since ...