A pilot scale for solid oral dosage forms is generally not less than 100,000 finished dosage units, which is mentioned in “Guideline on Stability Testing of Drug Substances and Products” (MOHW No.1041408733) announced on 11th March 2016. Can 10 percent of the proposed production batch size of the finished product for the dosage forms, except solid oral and special pharmaceutical dosage forms, be considered as a pilot scale batch size to support the stability of ANDA submission?
刊登日期：2019-11-22 | 點閱次數 : 1882 次
Yes. A pilot scale batch size for the dosage forms, except solid oral and special pharmaceutical dosage forms, can be at least 10 percent of the proposed production batch size of the finished product.
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