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发表于 2017-10-25 17:34:10
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然后,这并不仅仅是CFDA的要求,EMA 的指南中对于放大也有类似的要求。
It should be noted that pilot batch size should correspond to at least 10% of the production scale batch(i.e. such that the multiplication factor for the scale-up does not exceed 10). For solid oral dosage forms this size should generally be 10% of the maximum production scale or 100,000 units whichever is the greater1. Where the intended batch size is less than 100,000 units, the predictive value of the pilot batches may be limited and a justified approach should be followed. For other dosage forms the pilot batch size should be justified taking into account risk to the patient of failure of the dosage form.
以上出自Guideline on process validation for finished products - information and data to be provided in regulatory submissions(EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1,Corr.1)21 November 2016 |
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