How to Prepare for an MHRA Inspection: Temperature Control & Facility Compliance Checklist
Introduction: MHRA Inspections Don’t Have to Be Stressful
Whether you're running a pharmaceutical facility, a laboratory, or a clinical storage site, the words “MHRA inspection” can make even the most confident teams feel a little tense. And it’s understandable — the MHRA expects high standards, particularly when it comes to temperature control, monitoring, and environmental stability.
The good news? Preparing for an MHRA inspection doesn’t have to be overwhelming. With the right systems in place and a solid understanding of what inspectors look for, you can approach your audit with complete confidence.
Let’s break down exactly how to get your facility audit-ready — without the panic:
1. Understand What the MHRA Wants to See
The MHRA isn’t just checking whether your cold rooms or laboratories “seem fine.” They’re looking for evidence: evidence that your environments are controlled, your systems are validated, and your records are accurate and complete.
When it comes to temperature-controlled environments, inspectors expect to see:
- Precise control of temperature, humidity, and airflow
- Clear documentation of system performance
- Regular calibration, validation, and maintenance
- Fast detection and response to deviations
- Strong data integrity standards
In other words, they want to see that your environmental conditions are not left to chance — everything must be monitored, recorded, and proven.
2. Ensure Your Temperature Monitoring System Is Audit-Ready
This is where many facilities start to feel the pressure. If your temperature monitoring system is manual, inconsistent, or poorly documented, an inspector will spot it instantly.
A compliant system should:
- Record temperatures continuously
- Send real-time alerts for deviations
- Maintain secure historical records
- Provide easy-to-extract audit reports
Digital monitoring is the simplest way to achieve this. Automated data logging removes human error and ensures everything is timestamped, traceable, and easily accessible during an inspection.
3. Check That All Equipment Is Validated and Calibrated
Validation is a major focus during MHRA inspections. The inspector will want to see that your system has been fully qualified — from installation to performance — and that those results are documented clearly.
Your validation package should include:
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
Calibration is just as important. If sensors drift out of accuracy, your entire temperature data history becomes unreliable. Regular calibration with traceable certificates is non-negotiable for compliance.
4. Make Sure Your Documentation Is Clear and Easy to Access
One of the simplest ways to impress an MHRA inspector is to have your documentation ready to go — and properly organised. You should never need to “search” for a record during an audit.
Your team should be able to produce:
- Temperature logs
- Alarm records
- Calibration certificates
- Maintenance and repair reports
- Validation documents
- SOPs for environmental management
- Change control records
If your monitoring system is digital, most of this will already be stored, sorted, and exportable — which makes the inspection run far more smoothly.
5. Review Your Deviation and Corrective Action Records
No system is perfect, and the MHRA knows that. What matters most is how you respond when something goes wrong.
Inspectors will want to see:
- How you identified the issue
- How quickly you reacted
- What corrective actions were taken
- Whether you performed a root-cause analysis
- What measures were put in place to prevent recurrence
A well-handled deviation is not a problem — but an undocumented one definitely is.
6. Ensure Your Team Understands the Process
Even the best preparation can fall apart if the team isn’t aligned. Before an MHRA audit, make sure everyone understands:
- Who is responsible for each document
- How environmental monitoring works
- How deviations are escalated
- What the SOPs say
- What each system does and why it matters
Inspectors often ask staff to explain parts of the process. A confident, knowledgeable team shows that your facility is genuinely in control — not just preparing for the day.
7. Conduct an Internal Mock Inspection
One of the most effective ways to prepare for an MHRA audit is to run a practice inspection internally. This helps reveal weak spots before the real thing.
During a mock audit, ask:
- Could we easily show proof of temperature control?
- Is documentation up to date, accurate, and clear?
- Do we have evidence for every major process?
- Are our environmental monitoring systems reliable and validated?
- Would an inspector find inconsistencies?
- Identifying issues in advance will save you stress, time, and potentially serious compliance findings.
Conclusion: Confidence Comes from Preparation
MHRA inspections can seem intimidating, but with the right preparation, they don’t need to be. Strong environmental monitoring, complete documentation, regular validation, and a well-informed team form the foundation of an audit-ready facility.
At Laboratory Temperature Control, we support laboratories and pharmaceutical organisations across the UK with validated monitoring systems, GMP-compliant temperature control, and full documentation packages — everything you need to face an inspection with confidence.
If you’d like help preparing your environment for an MHRA audit, or you want to upgrade your monitoring systems before your next inspection, get in touch with our team today.






















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