Good manufacturing practice (GMP) regulators in the United States, Canada, European Union, Japan, Australia, and China have sharpened their focus on warehouse storage and distribution practices. Driving this trend is a shift in regulatory thinking from quality-by-test to quality-by-design systems with emphasis on level of risk to product quality and patient safety. Other drivers include greater demand for storage facilities due to globalization of manufacturing, increase in temperature-sensitive biopharmaceuticals, and changes in technology.
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