batch record
Think of a flight's complete logbook: who flew, what fuel was loaded, every checklist signed, every reading taken. The batch record is that logbook for a specific batch of medicine — the complete documented history of how that exact batch was manufactured, packaged and tested, capturing what was done, by whom, with what materials and equipment, and what the results were.
In practice it starts as a master batch record (an approved template, like a blank checklist) and becomes an executed batch record once an operator fills it in during production: lot numbers and quantities of every material, equipment used, each processing step with its actual parameters, in-process and finished-product test results, signatures and dates for every critical step, and any deviations and their investigations. Increasingly this is an electronic batch record in a manufacturing system rather than paper.
The batch record is the legal and scientific backbone of GMP, embodying the rule that what is not documented did not happen. A qualified person reviews and reconciles it before the batch can be released for sale, and if a problem later emerges in the field, the record is what makes a recall traceable. The honest discipline it demands is contemporaneous, accurate, attributable recording — back-dating, copying or completing entries after the fact is data-integrity fraud, not paperwork.
Before releasing a tablet batch, a quality reviewer checks the executed batch record: confirming the API lot was approved, the granulation parameters stayed in range, dissolution and assay passed, every critical step was signed at the time, and the yield reconciles.
Batch release hinges on the executed record reconstructing the whole manufacture.
Good documentation expectations are summarised by the acronym ALCOA: records should be Attributable, Legible, Contemporaneous, Original and Accurate — the foundation of data integrity.