Context: Review by Exception (RbE), in batch environments often referred to as Batch Review by Exception (BRBE), is a risk-based approach to reviewing electronic batch records. The validated eBR or MES system holds review rules that consistently evaluate mandatory entries, electronic approvals, step states, permitted process windows, material status and critical activities. Human review then addresses the flagged exceptions, their technical context and their significance for product quality, patient safety and regulatory compliance.
Why it matters: RbE reduces mechanical manual review effort, focuses QA and QP capacity on actual risks and can shorten release cycles. However, it replaces neither batch assessment nor release responsibility. It is only defensible if rules are validated, justified on a risk basis, changed under control and periodically reviewed for effectiveness.
Prerequisites:
- Structured, machine-readable batch data instead of scanned or unstructured documents.
- Validated exception rules based on process risk, specifications, critical parameters and defined acceptance criteria.
- A complete audit trail, data integrity in line with ALCOA+, and clear procedures for review, escalation, deviations and change control.
Distinction: RbE is neither a sampling-based review nor an automatic waving through of batches. The system handles repeatable checks; QA/QP continue to assess deviations, trends, unusual comments, open investigations and any matter that requires human technical judgement.
Short version: QA/QP primarily review quality-relevant exceptions and their context, while validated system rules handle the repeatable checks of the electronic batch record.
Further reading: