GMP Warehouse Mapping: Step-By-Step Guidelines for Validating Life Science Storage Facilities
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.
Regulators in these countries require “mapping” the temperature and relative humidity profile of warehouses for environmentally sensitive life science products. This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs, including many that have been published or revised recently. (See Regulations and Guidance at the end of this paper for more detailed citations of GMPs.) This guide, intended for use by any organization involved in the storage and distribution of products sensitive to temperature and humidity in a GMP-compliant environment, draws on Vaisala’s extensive customer experience throughout North America and Europe. Indeed, Vaisala’s environmental and industrial measuring and monitoring products are used in more than 140 countries.