How to Review GMP Documents Like a Pro
How to Review GMP Documents Like a Pro
1. Understand the Purpose of the Document
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Identify the type: SOP, Batch Manufacturing Record (BMR), Protocol, Validation Report, Logbook, etc.
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Ask: What is this document supposed to control, guide, or prove?
2. Verify Structure & Compliance
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Check if it follows the company’s document format (header, title, SOP number, version, approval, effective date).
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Ensure regulatory alignment (WHO, USFDA, EU GMP, ICH Q10).
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Confirm it includes Purpose, Scope, Responsibility, Procedure, Records, References, and Annexures (if needed).
3. Review for Accuracy & Clarity
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Language should be clear, precise, and unambiguous (avoid words like may, if possible, etc.).
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Technical terms and abbreviations should be defined.
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Instructions must be step-by-step and executable by trained personnel.
4. Check for Compliance with GMP Principles
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Traceability: Are signatures, dates, and version controls in place?
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ALCOA+ Principles: Data must be Attributable, Legible, Contemporaneous, Original, Accurate (+ Complete, Consistent, Enduring, Available).
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Safety & Quality: Does the procedure ensure product quality and patient safety?
5. Ensure Consistency
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Cross-check against related SOPs, guidelines, and regulatory requirements.
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Verify numbers, equipment IDs, and references (e.g., BMR matches SOPs, cleaning logs match equipment).
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Ensure consistency between flowcharts, tables, and text.
6. Look for Gaps & Risks
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Are critical steps missing (e.g., sampling, line clearance, reconciliation)?
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Are responsibilities clearly defined?
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Is deviation handling, change control, or CAPA covered (if applicable)?
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Does it cover what to do in case of an error or abnormal situation?
7. Formatting & Presentation
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Use professional formatting (headings, numbering, tables).
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Ensure controlled document footer (Doc. No., Version, Page x of y).
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Legibility: No overwriting, use black/blue ink, corrections properly documented.
8. Review Attachments & Records
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Are annexures, log formats, checklists, and forms attached and practical for use?
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Do record formats capture all required GMP data?
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Are they aligned with data integrity expectations?
9. Approval & Distribution
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Ensure review and approval by responsible functions: QA, Production, QC, Engineering, etc.
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Confirm controlled copies distribution list is maintained.
10. Ask Yourself (Final Check)
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If an auditor/inspector reviewed this, would it stand without explanation?
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Can a trained operator follow this document without confusion?
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Does it reduce the risk of GMP violations or product failure?
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