The envisioned result is a combined guideline, ICH Q1, with integrated annexes and/or appendices that address specific topics beyond the core stability recommendations and principles. Addressing drug product types including substances, intermediates, and devices.

The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States. It does not seek necessarily to cover the testing for registration in or export to

Jan 8, 2003 · This document defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the ICH regions. It does not cover the information to be submitted for abbreviated or abridged …

2 days ago · The ICH Q1 draft Guideline on "Stability Testing of Drug Substances and Drug Products" reached Step 2b of the ICH Process on 11 April 2025 and entered the public consultation period.A Step 2 Informational Presentation has also been developed by the Q1 EWG. Further information and the documents are available for download on the Q1 EWG page.

ICH Q1: Stability Testing of Drug Substances and Drug Products

ICH Q6A and Q6B should be consulted for recommendations on the setting and justification of acceptance criteria, and ICH Q1D should be referenced for recommendations on the use of full- versus reduced-design studies.

2 days ago · The International Council for Harmonisation (ICH) on 17 April issued its long-awaited update of its Q1 guideline on stability testing of drug substances and drug products. The new guideline consolidates the existing five stability guidelines into one and addresses new topics such as stability considerations for advanced therapies, bracketing and matrixing, stability …

The purpose of this revision is to harmonize the intermediate storage condition for zones I and II with the long-term condition for zones III and IV recommended in the ICH guidance Q1F...

Training materials developed by ICH Working Groups, ICH Training Associates and external Training Providers can be found in the below Training Library and under respective ICH Guideline as they become available.

Further guidance on new dosage forms and on biotechnological/biological products can be found in ICH guidances Q1C Stability Testing for New Dosage Forms and Q5C Quality of Biotechnological...