In a risk-based inspection (RBI), Schedule M points 14.3–14.5 are examined as high-impact controls because they govern how a firm handles nonconforming APIs/intermediates, recovered materials/solvents, and returned goods—all common sources of hidden quality defects, impurity drift, contamination, and data integrity failures.
14.3 Reworking
Inspectors confirm that reworking is never automatic. Before any rework decision, there must be a documented investigation into the reason for non-conformance. They verify that reworked batches receive appropriate evaluation/testing, stability testing where warranted, and documented evidence showing equivalent quality to product made by the original process. RBI focuses on whether the firm compares the impurity profile of each reworked batch against routine batches and uses additional analytical methods when routine methods are insufficient. Inspectors also check the validation approach (often concurrent validation for rework) and whether QA approval, change control, and full traceability are maintained.
14.4 Recovery of materials and solvents
RBI verifies that approved procedures exist for recovery (e.g., from mother liquor/filtrates) and that recovered materials meet specifications suitable for intended use. For solvents, inspectors check controlled recovery and monitoring to ensure solvents meet standards before reuse or commingling with other approved materials; they also verify when fresh and recovered solvents may be combined, based on testing evidence. All recovery and reuse decisions must be adequately documented.
14.5 Returns
Returned intermediates/APIs must be identified and quarantined. If storage/shipping conditions or container condition casts doubt on quality, the return must be reprocessed, reworked, or destroyed, as appropriate. RBI checks return records include consignee details, batch/quantity, reason for return, and final disposition.