Probably the best section to reference is Section 14.3 where it says that appropriate evaluation
testing, stability testing, if warranted, and documentation should be performed to show that the
rework product is of equivalent quality to that produced by the original process. We’re specifically
addressing rework. Reprocessing should follow normal production controls and specifications.
In section 11.2, for each batch of intermediate and API appropriate laboratory tests should be
conducted to determine conformance to specifications.
