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 | 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 | 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) | 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 Harmonised Tripartite Guideline: Stability Testing for New Dosage Forms FDA Q1C | | |
ICH Harmonised Tripartite Guideline: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products FDA Q1D | | |
ICH Harmonised Tripartite Guideline: Evaluation for Stability Data FDA Q1E | | |
Code of Federal Regulations: §211.166 Stability Testing | 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