Glossary
Batch Records
Also writtenbatch production recordbatch production and control record
All the documents that show how a particular batch was made and the circumstances bearing on its final quality.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Batch records Korean original
Details
Batch manufacturing records are the primary evidence from which the execution of a particular batch, and any event affecting its quality, can be reconstructed from beginning to end. Inspections look for missing critical process steps, actual values, signature times or deviations, for divergence from the master instruction, and for unexplained differences in yield or material reconciliation. Read the master production record, the executed batch record, equipment logs, yield and reconciliation, deviations, test results, and the release approval record as one connected chain.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, your QU failed to ensure: Established procedures were followed (21 CFR 211.22(d)) Batch records were reviewed before drug product release (21 CFR 211.22(a)) Use…
FDA · FDA Warning Letter · 2025-11-18 -
Your batch records were incomplete and did not contain batch specific data for compression machine reject limits.
FDA · FDA Warning Letter · 2022-12-06 -
For example, your firm failed to establish adequate procedures for reviewing and approving batch records prior to drug product release, annual product…
FDA · FDA Warning Letter · 2023-05-09
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Batch records Korean originalGRM Regulatory Glossary
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