Spring Intro 2023

28/03/2023

3.2.S.7 Stability

Comprehensive set of ICH guidelines cover the conduct of stability studies (how much data, what conditions and duration and interpretation of stability data – assigned shelf life and storage conditions

ICH Q1A

Stability Testing of New Drug Substances and Products

ICH Q1B

Photostability Testing of New Drug Substances and Products

ICH Q1C

Stability Testing for New Dosage Forms

ICH Q1D

Bracketing and Matrixing Designs for stability testing of New Drug Substances and Products

ICH Q1E

Evaluation of Stability Data

ICH Q1F

Stability data package for Climatic Zones III and IV

The Organisation for Professionals in Regulatory Affairs

29

The Drug Product Story

The Organisation for Professionals in Regulatory Affairs

30