报批美国FDA仿制药研发与问题探讨.pptVIP

Aspects Traditional QbD Pharmaceutical development Empirical; univariate experiments Systematic; multivariate experiments Manufacturing process Fixed; validation on 3 initial full-scale batches; focus on reproducibility Adjustable within design space; continuous verification; focus on control strategy Process control In-process testing for go/nogo; offline analysis w/slow response PAT utilized for feedback feed forward, real time Product specification Primary means of quality control; based on batch data Part of the overall quality control strategy; based on desired product performance Contr