The ISSCR Responds to ICH’s Q1 Guideline on Stability Testing of Drug Substances and Drug Products
On 28 July 2025, the ISSCR submitted a response to the International Council for Harmonisation’s (ICH) guideline on stability testing of drug substances and drug products. The ISSCR recommends adding specific examples to clarify appropriate applications of certain studies and incorporating considerations for diverse manufacturing models, particularly decentralized manufacturing, where products are administered immediately after production. The ISSCR also advises including guidance on pluripotent stem cell bank stability testing, referencing Tissue Engineered Products (TEP), and clarifying whether ATMP combined products are covered under the term “combination of a drug product with a medical device.”