ICH Issues Updated Draft of its Q1 Guideline on Stability Testing
ICH Issues Updated Draft of its Q1 Guideline on Stability Testing
The International Council for Harmonisation (ICH) issued an updated draft of its Q1 guideline on stability testing of drug substances and drug products on April 17, 2025. The most recent update to this guidance was published in 2003, so this revision is long awaited and addresses new topics such as ATMPs (Advanced Therapy Medicinal Products), bracketing and matrixing, stability modeling, as well as stability considerations for reference materials and novel excipients.
The guideline also exemplifies the standard stability data package required for regulatory submission for a range of product types, something that will be of great use to Regulatory Affairs professionals. The new guideline also includes new guidance on in-use studies, short term stability studies and processing / hold times. It is also great to see new guidance as it relates to the stability of novel excipients, recognizing the important role these materials play in overall drug stability.
The new guideline represents a significant rewrite of the existing guidelines and combines and modernizes the content of ICH Q1A-F series and ICH Q5C into a single comprehensive stability guideline, addressing a range of product types. When officially published it will provide a comprehensive approach to stability studies.
The draft guideline has now been approved at Stage 2 and will be issued for public commenting shortly.