cGMP Batch Record Review Checklist (21 CFR 211)

Record Completeness and Identity

Confirm the executed record accounts for the full batch.

• Is a unique batch/lot number assigned and traceable throughout the record? *
• Does the batch record reproduce the approved master production record with no unauthorized changes? *
• Are the product name, strength, dosage form, and batch size documented? *
• Record the theoretical yield stated in the master record.
• Are all pages present, sequentially numbered, and legible? *

Materials and Components

• Are the identity, lot numbers, and quantities of each component recorded and reconciled? *
• Do all components carry a released/approved disposition at the time of use? *
• Is weighing/dispensing verified by a second person or validated system? *

Processing and In-Process Controls

• Are equipment identification and cleaning/use log references recorded for each major step? *
• Were in-process controls performed and results within specification? *
• Are critical processing parameters (time, temperature, pressure, speed) documented? *
• Are second-person verifications performed for critical steps requiring them? *

Yield Reconciliation

• Record the actual yield achieved for the batch.
• Is the percentage of theoretical yield calculated and within established limits? *
• Is any yield discrepancy beyond limits investigated and documented? *

Deviations and Investigations

• Are all deviations, OOS results, and unexplained discrepancies recorded and cross-referenced to an investigation? *
• Are open investigations resolved or justified prior to disposition? *
• Describe any deviation affecting this batch and its impact assessment.

Labeling and Packaging

• Is labeling/packaging reconciliation completed with issued, used, and destroyed counts? *
• Was line clearance performed and documented before packaging? *

Quality Unit Review and Disposition

• Has the quality control unit reviewed and approved the complete batch record? *
• Do finished product test results meet the release specification? *
• Record the batch disposition decision (release, reject, hold). *
• Reviewer sign-off. *