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.

It is recommended that registration applications contain data from complete studies at the intermediate storage condition 30°C ± 2°C/65% RH ± 5% RH, if applicable, by three years after the date of publication of this revised guideline in the respective ICH tripartite region.

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.

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...

This guideline is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guideline “Q1A(R) Stability Testing of New Drug Substances and Products” (hereafter referred to as the parent guideline) to propose a retest period or shelf life in a registration application.

ICH Q1 F described harmonised global stability testing requirements in order to facilitate access to medicines by reducing the number of diferent storage conditions.

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...

seeks to exemplify the core stability data package required for new drug substances and products. It is not always necessar.

This training material is part of a larger set of trainings for ICH-Q1, thus we recommend you review the Q1B, Q1D & Q1E materials before proceeding.

Oct 23, 2021 · Details of the ICH guidelines for pharmaceutical quality from Q1 to Q14 including stability analysis, evaluation of impurities, quality risk management and analytical procedure development.