“Same as last time” is a poor batch instruction. It asks the next person to find the right previous batch, establish what happened, and decide which details still apply. A readable batch record puts that information beside the work.
Start with the batch and the instructions used
Identify the product, batch, formula version, and applicable manufacturing instructions. Record the actual material lots and quantities separately from the planned amounts. If two lots supply one ingredient, both contributions need to remain traceable.
FDA’s cosmetic GMP checklist includes material kinds, lots, quantities, processing, sampling, adjustments, and batch coding among its manufacturing-record subjects.
Compare two entries
These fictional entries show two ways of recording an adjustment:
Added more water. Checked again. OK.
A reviewer would need to ask which water lot was added, how much, and what the follow-up check showed. A fuller entry might read:
At 14:20, added 0.25 kg of water, lot W-107, under adjustment instruction A-06. Operator: JT. The follow-up result and method are attached as test T-42. Batch remains on hold pending the required review.
The second entry distinguishes the physical addition from its test result and review status. It also gives the reviewer references they can follow. The facility’s procedures determine the actual information and approvals needed.
Put exceptions where they happened
If production paused, a material was substituted, or a sample needed investigation, connect the entry to the relevant process step. Preserve the planned instruction and show the difference. Changing the original value to match the final result destroys the comparison a reviewer needs.
Before closing a record, follow one ingredient’s lot and quantity into the batch. Then follow an adjustment through its result and review. Add any missing references so the reviewer can retrieve those records.
For a longer example involving two filling runs, see batch traceability.
