Ice Lined Refrigerator chamber monitoring
The vaccines in Ice Lined Refrigerator products is addressed by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and the final guidance on Temperature testing has been adopted across Europe, Japan and the United States.
Furthermore, the FDA states in 21 CFR part 203 section that manufacturers, authorized distributors of drugs and their representatives shall store and handle all drug samples under “conditions that will maintain their temperature, integrity and effectiveness,” ensuring that the drug samples are free of contamination, deterioration and adulteration.
The vaccines in Ice Lined Refrigerator products is addressed by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and the final guidance on Temperature testing has been adopted across Europe, Japan and the United States.
Furthermore, the FDA states in 21 CFR part 203 section that manufacturers, authorized distributors of drugs and their representatives shall store and handle all drug samples under “conditions that will maintain their temperature, integrity and effectiveness,” ensuring that the drug samples are free of contamination, deterioration and adulteration.
Within the ice lined refrigerator chamber, parameters such as temperature, humidity, differential pressure, lighting, gas levels and other environmental conditions must be controlled, monitored and documented. To reduce the risk of failed studies, a monitoring system designed for both functionality and compliance is required. Functions should include data logging, automated date file backup, monitoring and reporting via Internet access, connectivity options including wireless, email, phone or text alarm notifications, multiple levels of data security, which can include digital signatures, complete event and interaction history and audit trail.
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