GMP Warehouse Mapping – Step-by-Step Guidelines for Validating Life Science Storage Facilities – Free PDF download




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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