Stability storage space available for products requiring environmental conditions based on ICH Q1A (R2) guidelines
DDL, Inc. announced today it is now offering off-site stability storage space capacity at its Eden Prairie, MN lab facility for products requiring environmental conditions based on ICH Q1A (R2) specified guidelines.
The purpose of stability testing is to provide evidence on how the quality of a drug substance, combination devices or drug product varies with time under the influence of a variety of environmental factors such as temperature and humidity, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions. Gathering stability testing data is a necessary step in the drug approval process.
“DDL is an experienced testing laboratory that offers efficient study management, flexible storage conditions and fast turn-around that satisfy all regulatory criteria for real time, accelerated or forced-degradation study requirements,” said Corey Hensel, General Manager, DDL, Inc.
DDL’s facilities contain rooms and chambers that have been mapped and calibrated for long- and short-term shelf life studies under various temperature and humidity requirements. DDL has the conditions and capacity needed to support tight timelines. Custom storage conditions and reports are available to support specific procedures and timelines.
Please contact us for more information on DDL’s ICH stability testing capabilities.