A short guide to stability studies
Stability testing is a vital element of ensuring a drug product is compliant with regulatory requirements, irrespective of whether you are submitting to the Food and Drug Administration (FDA), European Medicines Agency (EMA) or elsewhere. Stability studies ensure drug products remain stable during transportation, distribution, and storage, to maintain efficacy and safety throughout the lifetime of the product. Here Paul Barr, Principal Scientist at scientific consulting and testing specialist Broughton, outlines the key elements of stability testing for drug delivery devices.
The purpose of stability studies is to provide evidence on how the quality of the drug product varies with time under a variety of environmental factors and is a fundamental test as part of the submission framework for ensuring patient safety. Products that exhibit poor stability are one of the factors that mean that they are unlikely to be approved, and if problems arise later, can be recalled. An example of this occurred in 2018 when Hospira voluntarily removed 24,000 syringes of the injectable “Amidate” from the market when stability testing confirmed out of specification results1. Conducting stability studies can help ensure product safety, efficacy, and compliance, and the resulting data will become crucial to the manufacturer’s regulatory dossier.