Documentation Dosage units uniformity

The Q6A and Q6B documents were preceded by the North American Conference on Specifications. In all cases, no method selection, scope of application, or overall policy (dissolution, impmities, particulate matter, etc.) is at odds with USP, a remarkable condition in view of the breadth of the topics covered. The main difference is the proportion of active ingredient in a formulation that triggers choice of determination of content or of weight to establish Uniformity of dosage units. 

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 ... 

---