3.2.S.4.4 - Batch Analyses

Batch results for at least three batches manufactured according to the proposed manufacturing process and specification should be provided.

• Batch analysis to support significant variables of the manufacturing process should be provided, according to Annex II of this Resolution.

For new chemical entities, batch analysis of batches referenced in art. 37 of RDC 359/2020 should be provided.

Batch analysis should contain, at least, the following information:

1. Date of manufacture;
2. Size and batch number;
3. Site of manufacture;
4. Results for all tests listed in the specification

• The absence of tests that are listed in the specification or unexpected results should be justified.