How Often Should GMP Procedures Be Reviewed and Updated?
Good Manufacturing Practice (GMP) is not a “set it and forget it” system. Your GMP procedures must stay current with evolving regulations, product changes, and operational realities. So, how often should you review and update your GMP procedures?
The answer depends on a few key factors — but consistency and risk-based thinking are critical.
Why Reviewing GMP Procedures Is Essential
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Ensures compliance with local and international regulations
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Keeps practices aligned with evolving industry standards (e.g. ISO 22000, FSSC 22000)
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Prevents outdated or unsafe processes from continuing unchecked
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Supports training, audits, and operational excellence
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Reduces risk of non-conformities or regulatory penalties
General Guidelines for Reviewing GMP Procedures
1. At Least Annually
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Many auditors and regulators expect SOPs to be reviewed every 12 months
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Annual review ensures proactive compliance and continuous improvement
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Even if no changes are made, document the review with date and reviewer
2. After Key Changes in the Facility or Process
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New equipment or production lines
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Facility layout modifications
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Changes in raw materials, ingredients, or packaging
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Process optimization or automation upgrades
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Introduction of new product types or SKUs
3. Following Internal or External Audits
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Corrective actions may require SOP revisions
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Non-conformities often reveal gaps in existing procedures
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Use audit findings to trigger updates in relevant documentation
4. After Incidents or Deviations
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Any product recall, contamination, or quality failure
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Unexpected production stoppage due to GMP issues
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Deviations that reveal weak points in the current process
5. When Regulatory Requirements Change
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Updates in GMP laws, food safety acts, or licensing terms
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New guidance from WHO, FDA, PIC/S, or local authorities
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Industry trends (e.g., environmental or digital traceability standards)
6. Upon Employee Feedback or Observations
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Frontline staff may spot outdated or unclear procedures
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Encourage reporting of real-world challenges with SOPs
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Incorporate practical improvements to enhance usability and compliance
What to Include in a GMP Procedure Review
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Check accuracy and relevance of step-by-step instructions
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Verify references to equipment, raw materials, or forms are still valid
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Ensure job roles and responsibilities are up to date
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Confirm all linked documents (logs, checklists) are still being used
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Look for formatting or clarity issues that hinder implementation
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Add visual aids or flowcharts where possible
Best Practices for Document Control in GMP Systems
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Use version numbers and revision history
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Maintain a document master list with review dates
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Keep obsolete documents archived but not in use
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Ensure all staff are trained on new or updated procedures
How CAYS Scientific Can Help
At CAYS Scientific, we support your GMP program by:
✅ Auditing and updating outdated SOPs
✅ Designing a full GMP documentation system
✅ Training your team in proper GMP documentation control
✅ Ensuring alignment with ISO 22000, HACCP, and FSSC 22000 standards
📞 Contact CAYS Scientific today to make sure your GMP procedures are not just current — but audit-ready and risk-proof.
