Stability Studies: Regulatory Quick Links

Here is a quick place to find the key regulatory guidance on stability studies - if you need them.

Title	Link	Summary
Good Manufacturing Practices Guide for Drug Products	Health Canada GUI-0001	This is our go-to when we have questions. It references the ICH document but adds a lot of great useful information.
Good Manufacturing Practices for Active Pharmaceutical Ingredients	Health Canada GUI-0104	This is also one of our favourites. If these were documents and not hyperlinks you would see how dog-eared the pages would be.
ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products FDA Q1A(R2)	ICH Q1A(R2) FDA Q1A(R2)	All the information you need is here. Other documents refer to these guidance documents. It is an excellent place to start.
ICH Harmonised Tripartite Guideline: Stability Testing Photostability Testing of New Drug Substances and Products Q1B FDA Q1B	ICH Q1B FDA Q1B
ICH Harmonised Tripartite Guideline: Stability Testing for New Dosage Forms FDA Q1C	ICH Q1C FDA Q1C
ICH Harmonised Tripartite Guideline: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products FDA Q1D	ICH Q1D FDA Q1D
ICH Harmonised Tripartite Guideline: Evaluation for Stability Data FDA Q1E	ICH Q1E FDA Q1E
Code of Federal Regulations: §211.166 Stability Testing	CFR §211.166	U.S. Code of Federal Regulations that briefly outlines the requirement for having a stability study.
United States Pharmacopeia <1049> Quality of Biotechnological Products: Stability Testing of Biotechnological / Biological Products	Current version of USP	The requirements outlined in this chapter specifically reference the ICH Q1C. The chapter is described as an annex to the ICH guidance.

05 August 2022