这个蓝皮书上有一般的原则,应付国内检查足够用了。想看详细的,可以参考FDA的THE USE OF STRATIFIED SAMPLING OF BLEND AND DOSAGE UNITS TO DEMONSTRATE ADEQUACY OF MIX FOR POWDER BLENDS 还有Guidance for Industry Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessmentz这两本指南,但是目前没有中文版本。