§ 211.115 Reprocessing.
(a) Written procedures shall be established and followed prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics.
(b) Reprocessing shall not be performed without the review and approval of the quality control unit.
How BatchGlow handles this
Rework needs a QA-signed authorisation. Incorporating rework material into a new batch also needs its microbial clearance, and the share of rework in that batch is capped.
What it asks for, in plain words
- 21 CFR 211.115
- Written procedures describe how a batch that does not meet its standards or specifications is reprocessed so that it will. Reprocessing needs the review and approval of the quality control unit.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.