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.