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/ APPLICATION NOTE COLD CHAIN COMPLIANCE FDA & ICH: Regulations and Standards for TemperatureControlled Supply Chains In this application note we look at the FDA regulations and ICH guidelines that

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What is cold chain compliance?

Cold chain compliance refers to the adherence to regulations and guidelines regarding the transportation and storage of temperature-sensitive products to maintain their quality and safety.

Who is required to file cold chain compliance?

Any organization or individual involved in the transport or storage of temperature-sensitive products is required to file cold chain compliance.

How to fill out cold chain compliance?

Cold chain compliance can be filled out by providing accurate information on temperature monitoring, storage facilities, transportation methods, and handling procedures.

What is the purpose of cold chain compliance?

The purpose of cold chain compliance is to ensure the safety and quality of temperature-sensitive products throughout the supply chain.

What information must be reported on cold chain compliance?

Information such as temperature records, storage conditions, transportation methods, and handling procedures must be reported on cold chain compliance.

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