Lot Tracking
ProductionAlso known as: Lot traceability, Batch tracking, Lot number tracking
The system for tracing every unit of product back to the specific production batch it came from.
What It Means
Lot tracking assigns a unique identifier (lot number) to each production batch and maintains records connecting that lot number through every stage: raw material receipt, manufacturing, packaging, distribution, and sale. Under 21 CFR Part 111, supplement manufacturers must maintain batch production records that allow full traceability. If a quality issue or recall occurs, lot tracking identifies exactly which units are affected and which customers received them. Effective lot tracking requires the warehouse management system (WMS) to record lot numbers at receiving, pick-and-pack, and shipment.
What It Is Not
Lot tracking is NOT the same as serial number tracking (which tracks individual units). A lot/batch number covers all units produced in a single production run, which may be thousands of bottles. Lot tracking also does not verify product quality — it only ensures traceability if a quality issue is later discovered.
Evidence and References
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