Batch Traceability Explained

What is a batch?

A batch or lot is a defined quantity of material associated with a particular production, processing or packaging history.

The precise definition depends on the relevant quality system, but the purpose of a batch identifier is consistent:

• distinguish one material group from another;
• connect records to the applicable material;
• support investigation;
• support stock control;
• enable targeted withdrawal or quarantine;
• prevent documentation from being applied to the wrong material.

A product SKU and a batch number perform different functions.

• SKU identifies the product type.
• Batch number identifies a particular material lot.

One SKU may therefore have several active batches.

The traceability chain

A complete traceability chain may include:

1. Supplier identity
2. Supplier product reference
3. Purchase order
4. Supplier batch number
5. Shipping record
6. Date received
7. Quantity received
8. Condition on receipt
9. Internal SKU
10. Internal batch identifier
11. Storage location
12. Analytical sample identifier
13. Laboratory report number
14. Documentation-review status
15. Stock movements
16. Order or dispatch reference
17. Return, damage or disposal record

The system should allow a record to be followed in both directions:

• from supplier receipt to final dispatch;
• from a dispatched unit back to the applicable batch and records.

Supplier and internal batch numbers

A reseller may retain the supplier's original batch number, assign an internal batch number or use both.

Where an internal identifier is added, the relationship between the two must be recorded.

The internal identifier must not obscure:

• the original supplier batch;
• the source documentation;
• the receipt record;
• the material tested.

Relabelling and repackaging

When material is relabelled, divided or repackaged, the system should preserve a parent-child relationship.

The new record should identify:

• source batch;
• quantity transferred;
• date;
• staff member;
• new container identifiers;
• label version;
• reconciliation of quantities;
• rejected or damaged units.

A new label must not create the false impression that a new manufacturing batch has been produced.

Linking analytical reports

An analytical report should be linked using more than the product name.

Useful matching fields include:

• supplier batch;
• internal batch;
• laboratory sample ID;
• report ID;
• product and chemical form;
• date submitted;
• submitting organisation;
• quantity or sample description.

A report for one batch must not be automatically reused for a later batch.

Third-party testing ordinarily describes the submitted sample. The traceability system should document how that sample relates to the wider stock.

Inventory movements

Every change in stock should create an audit entry.

Movement types may include:

• initial receipt;
• additional receipt;
• reservation;
• sale or dispatch;
• cancellation release;
• return;
• damage;
• destruction;
• laboratory sample;
• correction;
• stock count adjustment.

A useful movement record contains:

• quantity before;
• change;
• quantity after;
• reason;
• reference;
• staff identity;
• timestamp;
• notes.

Movement history should be append-only. Corrections should create a new entry rather than silently rewriting the original event.

Data integrity

Reliable records should be:

• attributable;
• legible;
• contemporaneous;
• original;
• accurate.

They should also remain complete, consistent, enduring and available for the period in which they are needed.

Electronic systems should preserve:

• timestamps;
• user identity;
• change history;
• source records;
• controlled permissions;
• backups;
• audit trails.

A PDF may be useful as a report copy, but it may not contain all original instrument metadata.

Documentation status

The presence of a document is not the same as verification.

Useful statuses include:

• not received;
• received;
• under review;
• mismatch identified;
• verified for batch;
• superseded;
• rejected;
• archived.

Public-facing wording should describe the actual status and should not imply that verification has occurred when review remains incomplete.

Recall and investigation readiness

Traceability should make it possible to identify:

• how much of a batch was received;
• how much remains;
• how much was sampled;
• which orders received it;
• whether another batch was mixed with it;
• which documents apply;
• whether returned stock was reintroduced;
• who approved each decision.

A system that records only the current stock balance does not provide full traceability.

These sources describe established regulated-quality and data-integrity principles. Their citation does not state that PurePeps or its suppliers operate under the regulatory systems described.