The Batch Production Record (BPR) under 21 CFR 111.255 is the executed record for one batch, prepared from and matching the MMR. It must capture identity & weight/measure of each component used, in-process and finished-product specifications, equipment used, date and time of each significant step, identity of each person performing/verifying, sampling/test results, label reconciliation, deviations and their investigation outcome, and the QA disposition signature.

Regulatory anchors

21 CFR 111.255
21 CFR 111.260

How V5 handles it

QMS — quality records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Related terms

MMR elements per 21 CFR 111.205

BPR elements per 21 CFR 111.255

Next step

BPR elements per 21 CFR 111.255

Next step