This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II.

Apr 30, 2025 · This guideline provides comprehensive guidance to establish stability for all molecule types within its scope and includes recommendations on how science- and risk …

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 …

May 27, 2025 · April 2025 wurde der neue Entwurf der ICH Q1 Guideline "Stability Testing of Drug Substances and Drug Products“ veröffentlicht. Er stellt eine umfassende Überarbeitung und …

Apr 21, 2025 · Bei dem neuen ICH Q1-Dokument handelt es sich um eine konsolidierte Überarbeitung, die die ICH-Leitlinien Q1A-F und Q5C (Qualität biotechologischer Arzneimittel) …

Apr 18, 2025 · This updated guideline, endorsed on April 11, 2025, marks a crucial step towards harmonizing global stability testing practices for pharmaceuticals.

Apr 20, 2025 · This long-anticipated effort aims to unify ICH Q1A-F and Q5C into a single core document under the updated title ICH Q1. It is set to transform how stability data is generated, …

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.

May 20, 2025 · The new ICH Q1 Guideline is a comprehensive revision of the former Q1A–F and Q5C Guidelines. It expands the scope to synthetic and biological drug substances and …

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the …