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DRUG DISTRIBUTION TEMPERATURE CONTROL INITIATIVES

This article was originally published in The Gold Sheet

Executive Summary

...by industry and regulators are heading toward internationally harmonized solutions to the challenges involved. In view of more temperature-sensitive products and a more complex distribution chain, FDA and other regulatory agencies are working to develop and implement effective guidance and oversight in conjunction with industry and pharmacopeia efforts to develop viable, globally-relevant standards. Key temperature control issues include: ** how much monitoring is appropriate ** allowable excursions during transportation, and ** how to qualify the distribution process. [A discussion by an FDA compliance official of the initiative under way at the agency to assess cold chain problems and better target its regulatory response is provided.]
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