Anyone involved in the manufacture and distribution of time- and temperature-sensitive drugs over the past decade has seen a significant evolution to the process. Manufacturing has gone global, distribution has become more diversified and there has been a surge in the manufacture of new biologic drugs. Guidance and regulations have barely been able to keep up with the growing demand and popularity of these therapies. There has been an increased awareness by industry and additional scrutiny given by federal regulators (FDA and other global regulatory bodies) for more transparency and documentation to support medicinal products in distribution. This includes a seismic shift in attention given to drugs at controlled room temperature (CRT) conditions. Temperature assurance has extending well beyond the traditional boundaries of “cold-chain” —

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