Requirements for FDA Warehouse Validation

••• bugphai/iStock/Getty Images

Related Articles

In order to ensure the safety and effectiveness of pharmaceutical drugs and medical devises, the U.S. Food and Drug Administration established validation guidelines for proper warehouse storage. These regulations establish protocols for proving that storage facilities are equipped with fail-safe environmental controls and adequate monitoring and record-keeping systems. The aim is to keep products free from contamination.

In order to ensure the safety and effectiveness of pharmaceutical drugs and medical devises, the U.S. Food and Drug Administration established validation guidelines for proper warehouse storage. These regulations establish protocols for proving that storage facilities are equipped with fail-safe environmental controls and adequate monitoring and record-keeping systems. The aim is to keep products free from contamination.

FDA Validation

FDA regulations require proof of environmental controls for warehouse storage. Temperature and humidity must be maintained within acceptable ranges. Monitoring systems and sensors must be equipped with alarms that signal changes. The equipment also must be hooked up to backup power sources.

Equipment Testing

Guidelines require that warehouse equipment be tested and results reported to the FDA. The test equipment itself must be tested to ensure that data is constantly collected for reporting purposes, which is crucial in determining temperature changes or system vulnerability. Protocols for routine monitoring and reporting also must be tested and the results reported.

Systems Monitoring

Temperatures throughout the warehouse must be monitored for fluctuations and the information transmitted electronically to responsible supervisors. Monitoring may vary throughout the facility according to the required temperature and humidity standards for different product lines.

References

About the Author

A newsroom veteran since 1982, Gail Ferguson Jones has reported and edited for Dow Jones and "The Star-Ledger" in Newark, N.J., and has won first-place awards in deadline and spot-news reporting. Ferguson Jones is a Rutgers University graduate and completed a jounalism fellowship at the University of Missouri.

Photo Credits

  • bugphai/iStock/Getty Images