Batch & Expiry Traceability for Regulatory Compliance (Pharma, Agri, Food)
Batch and expiry traceability means your system records batch (and expiry) at receipt and sale and can report stock by batch, movements by batch, and which batches are affected by a recall. Regulators and auditors expect this in pharma, agri, and food for full compliance.
In this article
- Batch & expiry traceability: what regulators require
- How to set up batch tracking for regulatory compliance
- How to run a batch recall report
- What to record at receipt and at sale
Batch & expiry traceability: what regulators require
Batch (or lot) is the unit of traceability: one production run or one receipt. Regulators want to trace product from source to customer and back. So you must be able to say "this batch was received on X, sold to Y on Z" and "this batch is affected by recall." Batch-level reporting is the output of that traceability.
| Requirement | Your system must |
|---|---|
| Traceability | Record batch (and expiry where required) at receipt and at sale or issue |
| Stock by batch | Report current stock by batch/lot |
| Movements by batch | Report what was received, sold, or issued per batch |
| Recall readiness | Filter by batch (or range) and get stock + sales/allocations for affected batches |
How do I set up batch tracking for regulatory compliance?
At goods receipt, record batch (and expiry where required) for each line. Your system stores batch per movement. When you sell or issue, you assign or confirm the batch. Reports then show stock by batch, movements by batch, and "which batches were sold where."
How do I run a batch recall report?
When a batch is recalled, you filter by batch (or batch range) and get: current stock (to quarantine) and sales/allocations (to notify customers or trace). Your system should support "affected by batch" reports so you can act quickly.
For more on audit readiness, read navigating expiry date audits.
Batch-level reporting isn't just a report—it's the evidence that you can trace and recall when it matters. Record batch at receipt, use it at sale, and report by batch so regulators and customers are satisfied.