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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

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




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