How to Review GMP Documents Like a Pro

1. Understand the Purpose

• Identify what the document is for (e.g., SOP, batch record, protocol, report).

• Know the applicable GMP guidelines (US FDA, EMA, WHO, ICH).

2. Check for Compliance

• Ensure the document aligns with:

  • Current SOPs

  • Regulatory requirements

  • Internal quality standards

3. Verify Content Accuracy

• Data matches source records.

• No transcription or calculation errors.

• Batch details, equipment IDs, and material lot numbers are correct.

4. Review Formatting & Structure

• Correct document title, unique number, and version/revision history.

• Sections are complete—no blank or unfilled mandatory fields.

• Approved templates used.

5. Assess Data Integrity (ALCOA+)

• Attributable: Who recorded the data?

• Legible: Clear handwriting/printing.

• Contemporaneous: Recorded in real time.

• Original: Not rewritten without justification.

• Accurate: Matches facts; no unauthorized changes.

6. Look for Red Flags

• Missing signatures or dates.

• Unexplained corrections or overwriting.

• Out-of-sequence events.

• Deviations not documented or explained.

7. Confirm Review & Approval Flow

• Reviewed and signed by authorized personnel.

• QA/QC final review before release or filing.

8. Cross-Check References

• Linked SOP numbers are valid and current.

• Test methods and specifications match approved versions.

9. Keep a Reviewer’s Checklist

• Create a standard checklist for all GMP document reviews to ensure nothing is missed.

Pro Tip:

Always review with a critical, investigative mindset—assume the regulator will scrutinize it next.

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