Batches and products

The Production Manager starts each lot with a batch number and a product. The product record gives the team a stable product code, dosage form, strength, storage condition and shelf-life basis. On the batch, the manager records quantity, unit, manufacturing date, expiry date, line and site. These details let quality control distinguish one lot from another while it reviews testing and exceptions.

A product can be in development, marketed or discontinued. The team should agree how those states affect its manufacturing practice before entering the first working lot. Each batch has its own lifecycle. A planned batch can move into production, testing, quarantine, approval and release; rejected and recalled states remain visible for the lots that need them. The person changing status should be able to explain the evidence behind the choice.

• Product identity. Keep the product code and name consistent across batches, specifications and release decisions.
• Lot identity. Give each batch its own number and production context, even when several lots share a product.
• Lifecycle review. Use status to show what the team has actually completed, with a separate decision record for release judgment.

Settle who creates product records and who can alter a batch after it enters testing. Agree on the batch numbering convention, supported units and the meaning of each production line and site value. Review which products require a storage condition and shelf-life entry. Those product details are useful only if the team keeps them current when a lot is planned.

The team should also decide how it handles a quarantined lot. A status change should direct attention to the lot; the investigation and test outcomes live in their own records. Do not make a batch status stand in for a quality decision. Production Manager and QA Manager should rehearse this boundary with a real lot before routine use.

Take a tablet product with a recorded strength and create a manufacturing lot with its batch number, quantity, line and expiry date. Move the lot through production into testing. QC Analyst records results against the applicable product specification. If a test raises a concern, QA Manager links a deviation to that same batch and reviews it before approval. Qualified Person records the release decision separately before QA Manager marks the batch Approved. Every Approved batch enters the posting workflow, which changes it to Released and creates a receipt for that performed operation.

Compare the batch, its test results, deviation, decision and receipt. They should all point to the same lot. If a later concern calls for recall, the batch remains identifiable by product, number and site. The receipt still describes the release operation that happened earlier.

• Batch lifecycle board — Lots grouped by their current manufacturing and review status.
• Batches awaiting quality review — Testing, quarantined and approved lots gathered for the quality handoff.
• Approved batches for release — Approved lots that enter the release posting path.

See batch quality to release for the full handoff and release review for the decision and posting steps.