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FDA & ICH: Regulations and Standards for Temperature-Controlled Supply Chains

Thu, 08/16/2012 - 8:57am
Vaisala

The Vaisala CCL100 Cold Chain temperature logger might be simple and easy, but the regulations governing cold chain monitoring are complex. Read this new Application Note, "FDA & ICH: Regulations and Standards for Temperature-Controlled Supply Chains" for help demystifying these regulations. This paper discusses a scientific approach to cold chain management, overview of ICH guidance, three key FDA regulations, and examples of cold chain 483 observations.

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