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What Should You Do After Receiving a GMP Warning Letter

By June 24, 2025No Comments

What Should You Do After Receiving a GMP Warning Letter?

Receiving a GMP Warning Letter from the Ministry of Health (MOH), NPRA, or a certification body can feel intimidating — but it’s not the end of the road.

With a clear action plan, you can respond professionally, correct the issues, and restore your GMP compliance status.

🚨 What Is a GMP Warning Letter?

  • An official notification that your facility has violated GMP requirements

  • Issued after:

    • MOH/NPRA inspections

    • GMP certification audits (including ISO-based schemes)

  • Highlights specific non-conformities, often linked to:

    • Poor documentation

    • Hygiene issues

    • Incomplete SOPs

    • Untrained staff

    • Cross-contamination risks

📉 Potential Consequences If Ignored

  • Product seizure or license suspension

  • Withdrawal of GMP certificate

  • Damage to brand reputation

  • Legal or export complications

  • Loss of customer trust or retail partnerships

✅ What To Do Immediately After Receiving a GMP Warning Letter

1. Don’t Panic — But Act Quickly

  • Note the response deadline (usually 14–30 days)

  • Inform top management and relevant department heads immediately

2. Read the Letter Carefully

  • Identify all observations, citations, and required actions

  • Clarify technical terms with QA or consultants if needed

3. Assess Each Non-Conformance

  • Categorize findings:

    • Documentation gaps

    • Process failures

    • Hygiene or facility issues

  • Identify if they’re isolated or systemic

4. Gather Internal Evidence

  • Pull all related SOPs, records, cleaning logs, and photos

  • Note whether non-conformances were:

    • Previously addressed

    • Due to expired procedures

    • Caused by training or human error

5. Develop a Corrective and Preventive Action (CAPA) Plan

  • For each finding, include:

    • Root cause analysis

    • Immediate corrective actions

    • Long-term preventive steps

    • Timeline for completion

    • Assigned responsible person

6. Document Everything Clearly

  • Use a structured response template

  • Attach supporting documents (photos, training records, revised SOPs)

  • Ensure your tone is professional, cooperative, and proactive

7. Submit a Formal Response On Time

  • Send to the correct authority (NPRA / audit body / MOH department)

  • Keep copies of all correspondence

  • If needed, request a reasonable extension — but don’t delay without communication

🛠 Ongoing Improvements After the Letter

🔄 Conduct a Full Internal Audit

  • Review all processes and GMP areas — not just the ones cited

  • Identify other gaps before the next inspection

🧑‍🏫 Retrain Staff

  • Conduct focused GMP refresher training

  • Emphasize hygiene, documentation, and SOP compliance

📋 Revise SOPs and Records

  • Update outdated procedures

  • Simplify complex documentation

  • Ensure version control and proper approvals

🧼 Improve Facility Conditions

  • Upgrade sanitation zones, drainage, and ventilation if needed

  • Improve zoning, pest control, and cleaning schedules

📆 Schedule a Follow-Up Audit

  • Engage a consultant for a mock GMP audit

  • Ensure you’re ready before inviting the authority back for reinspection

📌 Final Thoughts

A GMP warning letter doesn’t mean failure — it’s an opportunity to strengthen your food safety system and prevent future penalties.

The key is to:
✅ Respond clearly
✅ Act quickly
✅ Show genuine commitment to improvement

The faster and more effectively you respond, the sooner you can regain GMP compliance — and your stakeholders’ trust.

💼 Need expert help responding to a GMP warning letter or preparing for reinspection?
At CAYS Scientific, we support Malaysian factories and SMEs with:
✔️ Root cause analysis
✔️ CAPA planning
✔️ SOP updates
✔️ Staff retraining and mock audits

📞 Let’s resolve your non-compliances — and restore your GMP confidence.

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