US FDA
21 CFR 211.188 - Batch Production and Control Records
Plain-language explanation, inspection context and common violation patterns.
What it says
Complete batch production and control records must be prepared for each batch, including accurate reproduction of the master production and control record, documentation that each significant step was accomplished, identification of equipment and personnel involved, and results of in-process and laboratory testing performed.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- The batch record must be an accurate, contemporaneous account of what actually happened, not a reconstruction assembled afterward from memory or informal notes.
- Every significant manufacturing step requires documented evidence it occurred as specified, including who performed it and, where applicable, who verified it through a second-person check.
- Component and material reconciliation, connecting theoretical quantities to actual quantities used, is part of what a complete batch record must demonstrate.
What FDA inspectors look for
- Whether batch record entries are contemporaneous with the actual manufacturing step, based on ALCOA+ principles, rather than completed retrospectively.
- Whether blank fields, missing signatures or undocumented corrections appear in reviewed batch records.
- Whether component reconciliation is documented and any discrepancy beyond the approved range is investigated.
Most common violation
Batch record entries completed after the fact rather than at the time each step was performed, and blank or unexplained gaps in the record discovered only during quality unit review rather than caught contemporaneously.
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