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How Do You Prepare for a Third-Party GMP Audit

By June 14, 2025No Comments

How Do You Prepare for a Third-Party GMP Audit?

Getting ready for a third-party GMP audit can feel overwhelming — but with the right steps, it becomes a structured and manageable process.

Whether you’re a food manufacturer, supplement producer, or trading company, this checklist will help you confidently prepare, avoid non-conformities, and pass your GMP audit the first time.

🎯 Why Third-Party GMP Audits Matter

  • Confirms your facility meets Good Manufacturing Practice standards

  • Required for:

    • Customer approval

    • Regulatory compliance

    • Market access and exports

  • Builds trust with buyers and retailers

  • Reduces risks of recalls, contamination, or enforcement action

✅ Pre-Audit Preparation Checklist (GMP Audit Readiness)

1. Review Your GMP Standard or Certification Criteria

  • Understand which standard applies:

    • Malaysian GMP (NPRA / MOH)

    • ASEAN GMP

    • Codex GMP or industry-specific versions

  • Cross-check all clauses and requirements

2. Conduct an Internal GMP Audit

  • Use an internal checklist based on the GMP standard

  • Identify:

    • Gaps in documentation

    • Incomplete records

    • Staff non-compliance

  • Correct all findings before the third-party audit

3. Update and Organize Documentation

  • Prepare:

    • SOPs (Standard Operating Procedures)

    • Cleaning logs

    • Pest control records

    • Equipment maintenance logs

    • Training records

  • Ensure everything is:

    • Signed

    • Dated

    • Version-controlled

4. Train Employees on GMP Awareness

  • Cover:

    • Personal hygiene

    • Cross-contamination prevention

    • Correct recordkeeping practices

  • Conduct a mock Q&A session to prepare staff for auditor interviews

5. Inspect Your Premises

  • Check:

    • Cleanliness of production and storage areas

    • Layout and material flow

    • Pest-proofing and waste handling

    • Proper signage and zoning

  • Make necessary improvements in advance

6. Test Emergency Preparedness

  • Have SOPs and evidence for:

    • Fire drills

    • Product recall procedures

    • First-aid readiness

  • Show you can respond to incidents without chaos

7. Verify Calibration and Equipment Validation

  • Ensure:

    • Calibration certificates are up to date

    • Scales, thermometers, and critical equipment are tested

    • Validation reports are available for key processes

8. Communicate the Audit Schedule

  • Inform:

    • All departments about audit date and scope

    • Line leaders to assign roles and responsibilities

  • Assign a GMP audit coordinator to guide the process

🚫 Common Mistakes to Avoid Before a GMP Audit

  • Last-minute document updates

  • Dirty or disorganized production areas

  • Missing training or calibration records

  • SOPs that don’t match actual practice

  • Untrained staff unable to answer auditor questions

📁 Key Documents Auditors Will Ask For

  • GMP Manual or Quality Policy

  • Master list of SOPs and records

  • Training matrix and staff sign-offs

  • Internal audit reports and CAPA records

  • Supplier approval forms

  • Cleaning and sanitation logs

  • Product traceability records

🧠 Extra Tips to Impress the Auditor

  • Prepare a clean, organized audit room with document folders

  • Designate someone to escort the auditor and take notes

  • Be honest — if you don’t know an answer, offer to check and follow up

  • Focus on food safety culture, not just paperwork

🧩 Final Thoughts

A third-party GMP audit doesn’t have to be stressful — it just takes advance planning, staff awareness, and organized systems. When your team is trained and your records are in order, you’ll be audit-ready anytime.

💼 Need help preparing for a third-party GMP audit?
CAYS Scientific helps Malaysian food factories and SMEs with mock audits, training, documentation reviews, and full GMP compliance support. Let’s get you ready — and certified with confidence.

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