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  Pharmaceutical Cold Chain Compliance

A cold chain is a temperature-controlled supply chain. Cold chains are common in the food and pharmaceutical industries and also some chemical shipments. One common temperature range for a cold chain in pharmaceutical industries is 2 to 8 C. Members of the pharmaceutical supply chain have various global regulatory requirements to meet while handling, storing, and distributing environmentally sensitive products. The selection of a temperature monitoring system (chemical, mechanical or electronic) is determined by the amount of information required. Electronic temperature data loggers provide valuable information in a convenient format. Medicines requiring controlled-temperature storage conditions must be distributed in a manner that ensures their quality will not be adversely affected. Due to the presence of multiple uncontrolled variables in the distribution process, developing an appropriate temperature and humidity monitoring program is essential to protect the quality of environmentally sensitive pharmaceutical product and ensure patient safety. Cold chain gap analysis shall apply onto all sectors that have a potential impact on the cold chain and product integrity. The course is designed to learn how to maintain temperature throughout the entire cold chain and provides participants an intricate knowledge of all aspects of cold chain and temperature sensitive supply chain key components.

Date: 25, Apr 2013 Posted By: admin
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