Batch Production Record Review Checklist

Batch production record QA review is a prerequisite for drug product release. This checklist guides systematic review of BPR completeness, data integrity, and compliance with 21 CFR 211.188 requirements before quality disposition decision.

Industry: Pharmaceutical & Life Sciences
Frequency: Per Batch (Pre-Release Review)
Estimated Time: 45-90 minutes
Role: QA Manager / Quality Director
Total Items: 33
Compliance: FDA 21 CFR 211.188 Batch Production and Control Records, FDA 21 CFR Part 11 Electronic Records Electronic Signatures, ALCOA+ Data Integrity Principles (FDA Guidance 2018), EU GMP Chapter 4 Documentation, ICH Q10 Pharmaceutical Quality System

Record Completeness

Verify BPR is complete with no blank fields.

No blank fields - all steps completed or marked N/A with justification?
All required steps initialed or signed by qualified personnel?
All steps dated with times where required?
No evidence of post-hoc entries (late additions not flagged as such)?
All corrections made per SOP (single line strikethrough, initials, date, reason)?
Pre-production checklist (line clearance, equipment, materials) complete?

Data Integrity and ALCOA+

Verify data integrity compliance throughout batch record.

All entries attributable to specific person (no group logins, no initials for others)?
All entries legible and in indelible ink (no pencil)?
Original raw data (chromatograms, printouts) attached or referenced and available?
No unauthorized deletion or alteration of original data in electronic systems?
Electronic audit trails enabled and not altered?
Critical steps verified by second qualified person?

Materials and Components

Verify material use and documentation.

All components listed are from approved suppliers with approved lot numbers?
Certificate of Analysis (CoA) on file for all materials used?
Quantities of materials used match BPR instructions?
No expired or retest-due components used?
Label reconciliation complete - issued vs. used vs. destroyed documented?

In-Process Controls and Test Results

Review in-process control results.

All in-process control (IPC) results within specification?
Any OOS/OOT in-process results documented and investigated per OOS SOP?
In-process environmental monitoring results acceptable?
Theoretical vs actual yield within acceptable range?
Yield reconciliation calculated and within limits?

Equipment Documentation

Verify equipment use documentation.

Equipment IDs documented for all major equipment used?
All critical instruments used are within calibration period?
Equipment cleaning logs referenced and cleaning validated?
All equipment within preventive maintenance schedule?
Equipment use logbooks complete for all major equipment?

Deviations and Batch Release

Review deviations and final release determination.

All deviations during batch manufacture documented with deviation numbers?
Quality impact assessment completed for all deviations?
No critical deviations requiring batch rejection?
All required QC release testing results available and within specification?
Stability samples pulled and logged per stability protocol?
Batch disposition decision made by authorized QA personnel?

Related Pharmaceutical Life Sciences Checklists

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Why Use This Batch Production Record Review Checklist?

This batch production record review checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / quality director professionals, this checklist covers 33 critical inspection points across 6 sections. Recommended frequency: per batch (pre-release review).

Ensures compliance with FDA 21 CFR 211.188 Batch Production and Control Records, FDA 21 CFR Part 11 Electronic Records Electronic Signatures, ALCOA+ Data Integrity Principles (FDA Guidance 2018), EU GMP Chapter 4 Documentation, ICH Q10 Pharmaceutical Quality System. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Batch Production Record Review Checklist cover?

This checklist covers 33 inspection items across 6 sections: Record Completeness, Data Integrity and ALCOA+, Materials and Components, In-Process Controls and Test Results, Equipment Documentation, Deviations and Batch Release. It is designed for pharmaceutical & life sciences operations and compliance.

How often should this checklist be completed?

This checklist should be completed per batch (pre-release review). Each completion takes approximately 45-90 minutes.

Who should use this Batch Production Record Review Checklist?

This checklist is designed for QA Manager / Quality Director professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.