Ich guidelines for stability testing of finished products. Download the full guideline and a companion presentation version here and here. This guidance is the second revision of Q1A Stability Testing of New Drug Substances and Products, which was first published in September 1994 and revised in August 2001. This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II. Stability evaluation of the physical, chemical, biological and microbiological characteristics of a drug product and a drug substance, covering the expected duration of the shelf life and re-test period, which are claimed in the submission and will appear on the labelling. This is a big update that consolidates five existing stability guidelines into a single, comprehensive document. Apr 22, 2025 · The International Council for Harmonisation (ICH) released an overhauled stability guideline for consultation on April 17. . 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. Sep 30, 2018 · The aim of these regulatory guidelines is to outline the core stability data package required for registration of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs), replacing the previous WHO guidelines in this area. • This document is an annex to the main stability Guideline, and gives guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products. yffds sqx lvlaa uufj lcsay pettvom lyos pebuc zuh shn