Blend uniformity, assessment sample locations

The guidance document recommends that during the manufacture of demonstration and process validation batches, the following uniformity characteristics be assessed (1) the powder blend, (2) the in-process dosage units, and (3) the finished product. Each attribute should be determined independently. It is further recommended that the following steps be used to identify sampling locations and acceptance criteria prior to the manufacture of the exhibit and/or validation batches ... 

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