Stability testing studies are an essential component of pharmaceutical development. 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.
Working with an experienced partner who offers efficient study management, flexible storage conditions and testing capabilities which satisfy all regulatory criteria for your real time, accelerated or forced-degradation study requirements is important.
Our team provides stability storage space for products requiring environmental conditions based on ICH Q1A specified guidelines. Our laboratories in Eden Prairie, MN and Irvine, CA contain over 25,000 cubic feet of storage space that have been mapped and calibrated for long- and short-term shelf life studies under various temperature and humidity requirements.
We have the conditions you need and the capacity to support your tight timelines. Custom storage conditions and reports are available to support your specific procedures. Whether you require storage only, storage and package testing, package testing only, and/or project management assistance, DDL is here to assist you.
- ICH Q1A Stability Testing of New Drug Substances and Products
- ICH Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
Contact us for more information or to talk to an engineer.