To validate your storage facility for GMP compliance, you must document and verify that your environment consistently maintains required conditions (e.g. temperature, humidity), meets GMP requirements, and follows standard operating procedures for monitoring, calibration, and maintenance. Validation involves risk assessment, equipment qualification, and ongoing audits.
What is GMP validation for a storage facility?
GMP validation ensures that a pharmaceutical storage facility can consistently and reliably store products under storage conditions that preserve quality and safety. This includes validating environmental control systems (like temperature and humidity), ensuring SOPs are followed, and proving compliance with regulatory requirements such as those from the TGA, PIC/S, or FDA.
Validation typically involves equipment qualification (IQ, OQ, PQ), establishing monitoring systems, calibrating sensors, and documenting results to prove ongoing control.
Why is storage facility validation required under GMP?
Without validated systems, storage conditions can fluctuate — leading to product degradation, safety risks, and regulatory violations. GMP compliance protects patient safety by ensuring medicines are stored securely and stable throughout their shelf-life.
Regulators like the Therapeutic Goods Administration (TGA) in Australia and PIC/S members globally require documented evidence of storage compliance for both manufacturing sites and clinical trial storage.
What documents are needed to validate a GMP storage facility?
A complete validation file typically includes:
- Validation protocol (approved plan)
- Equipment qualification records
- Traceable Calibration certificates for all sensors and loggers
- Environmental monitoring reports
- Deviation logs and corrective actions
- SOPs for monitoring, maintenance, and alarms
- Final validation report signed by Quality Assurance
These documents demonstrate that storage conditions are controlled, reproducible, and compliant with GMP storage requirements, ensuring regulatory confidence in your facility’s ability to maintain product integrity.
How do I monitor temperature and humidity in a GMP facility?
Use validated data loggers or environmental monitoring systems with built-in alarms and reporting. These should be:
- Calibrated regularly
- Capable of real-time monitoring
- Connected to a secure data logging platform
- Auditable for out-of-spec events
All readings must be recorded, reviewed, and backed up. Many facilities choose automated monitoring systems that can send alerts via email or SMS for quick corrective action.
What is a risk assessment in GMP validation?
A risk-based approach is encouraged under ICH Q9(R1) and the PIC/S GMP guide. This means assessing:
- What could go wrong (e.g. temperature excursions)
- How likely it is
- What the impact would be
- What controls are in place to prevent it
This helps prioritise validation activities and reduces unnecessary over-validation.
How often should GMP storage facilities be revalidated?
Typically, revalidation is done:
- Annually, or
- After any significant change, such as equipment replacement or layout modification
Routine audits and continuous monitoring support a state of ongoing validation — which is expected under ICH Q10 (Pharmaceutical Quality Systems).
What happens during a GMP inspection of your storage facility?
Inspectors will:
- Review your validation documentation
- Check your monitoring systems
- Ask about calibration schedules
- Examine your SOPs and deviation handling
- Evaluate your risk management approach
Facilities with clear, well-maintained records and a robust quality culture typically pass inspections more easily.
Key Takeaways
- You must validate your pharmaceutical storage facility to prove GMP compliance.
- This includes monitoring temperature and humidity, qualifying equipment, and documenting everything.
- Use risk-based frameworks like ICH Q9 and PIC/S to streamline the process.
- Revalidation should happen regularly or when changes occur.
- A compliant facility protects patients, product quality — and your regulatory compliance.
Need help with GMP validation or preparing for inspection?
Explore our GMP Storage Services or speak with our experts.
