Can Your GMP Records Survive a Surprise Audit?

A well-maintained GMP record system can make or break your next audit — especially if it’s unannounced.

Surprise audits are becoming more common from NPRA, MOH, certification bodies, and even key retail customers. The question is:
👉 Are your GMP records audit-ready right now?

Let’s explore what GMP auditors are looking for, the common recordkeeping gaps, and how to ensure your documents can stand up to scrutiny — anytime.

📋 Why GMP Records Are So Important

• Records provide evidence of compliance with GMP requirements

• Show that processes were followed correctly and consistently

• Help trace who did what, when, and how

• Required by:

  • NPRA (Malaysia)

  • ISO 22000, FSSC 22000

  • Internal QA teams and certification audits

• If it’s not documented, auditors assume it didn’t happen

⚠️ What Happens When Records Are Incomplete or Inaccurate?

• Major non-conformities during audits

• Loss of certification or license

• Product recalls or market withdrawals

• Legal risks and reputation damage

• Rejection by retailers, importers, or regulatory bodies

🕵️ What Do GMP Auditors Look for in Records?

1. Completeness

• All required logs are filled out fully

• No missing signatures or skipped sections

• Covers daily, weekly, and monthly records

2. Accuracy

• No suspicious corrections or white-outs

• Consistent data (e.g., temperature logs match production records)

• Clear handwriting or printed entries

3. Timeliness

• Records completed in real-time, not backdated

• Entries made on the day of the activity

4. Traceability

• Each record clearly shows:

  • Operator name/signature

  • Date and time

  • Product or batch code

• Linked to batch release or product quality

5. Retention and Accessibility

• Archived properly (paper or digital)

• Easily retrievable during inspection

• Retained for required period (often 1–5 years, depending on product type)

✅ Types of GMP Records You Must Keep Audit-Ready

• Production records (batch sheets, mixing logs)

• Cleaning and sanitation logs

• Equipment calibration and maintenance logs

• Pest control service reports

• Training attendance and materials

• Environmental monitoring records

• Material receiving and traceability records

• Internal audit findings and CAPA reports

🛠 How to Make Your Records Audit-Proof

📆 1. Set a Documentation Routine

• Daily, weekly, and monthly record checkpoints

• Assign responsible staff to review and file records

🧑‍🏫 2. Train All Staff on Good Documentation Practices (GDP)

• Use black or blue pen only

• No blank fields — use “N/A” when not applicable

• Sign and date everything immediately

📁 3. Use Templates or Digital Logs

• Pre-approved record templates reduce errors

• Digital systems offer reminders and time-stamps

🔍 4. Conduct Regular Internal Reviews

• Spot errors before auditors do

• Check for:

  • Missing pages

  • Illegible handwriting

  • Incomplete forms

🧾 5. File and Back Up Records Securely

• Store by department, month, and record type

• Use both physical and cloud-based storage, where possible

🚨 Red Flags Auditors Often Find

• Records completed in pencil or erasable ink

• Logs filled out all at once at the end of the shift

• Pages missing from cleaning or batch logs

• Untrained personnel signing off on critical activities

• Files not available on request (“someone took it home”, “it’s in storage”)

📌 Final Thoughts

If an auditor walked in today, would your GMP records:

✅ Be complete and signed?
✅ Show clear traceability?
✅ Be accessible within minutes?

If the answer is “maybe” — it’s time to act.
GMP documentation isn’t just about paperwork — it’s about proving your facility runs safely, consistently, and professionally.

💼 Need help preparing for a GMP audit or fixing your documentation system?
At CAYS Scientific, we support Malaysian SMEs with:
✔️ GMP and ISO-compliant record templates
✔️ Internal audit support
✔️ Team training on documentation best practices
✔️ Mock audits for real-world readiness

📞 Contact us today and make sure your records are ready — anytime.