Q1A(R2) - ICH
...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....
https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf
ICH Q1A (R2) Stability testing of new drug substances and drug products ...
...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....
https://www.ema.europa.eu/en/ich-q1a-r2-stability-testing-new-drug-substances-drug-products-scientific-guideline
ICH Official web site : ICH
...This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II....
https://www.ich.org/page/quality-guidelines
ICH Q1A(R2) Guideline - IKEV
...1. Introduction 1.1 Objective of the Guideline Revised version of ICH Q1A, defines stability data package or drug substance and drug product for registration application, within three regions of ICH, EC, Japan USA does not cover testing for registration in or export to other areas of the world...
https://www.ikev.org/haber/stabilite/kitap/29%201.1%20Stability%20Workshop%20ICH%20Q1AR2%20C.pdf
ICH Q1A (R2) Stability Testing of new drugs and products (Revised ...
...This revised ICH guidelines regulate the scope necessary for marketing authorization of the stability testing of new active substances and finished medicinal products containing new active substances....
https://www.gmp-compliance.org/guidelines/gmp-guideline/ich-q1ar2-stability-testing-of-new-drugs-and-products-revised-guideline
Q1 Stability Testing of Drug Substances and Drug Products
...This draft guidance is a consolidated revision of the ICH Q1A (R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003,......
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q1-stability-testing-drug-substances-and-drug-products
ICH Topic Q 1 A (R2) - Therapeutic Goods Administration (TGA)
...ICH Topic Q 1 A (R2) - Stability testing of new drug substances and products We have adopted this International Scientific Guideline ? ICH Q1A (R2); CPMP/ICH/2736/99...
https://www.tga.gov.au/resources/resource/international-scientific-guidelines/ich-topic-q-1-r2-stability-testing-new-drug-substances-and-products
Stability tests according to ICH Q1A (R2)
...In 1990, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was born. This paper summarises the main contents of Guideline ICH Q1A (R2), which deals with the stability testing of new drug products and new drug substances....
https://www.fishersci.fr/content/dam/fssite/eu/brands/m/memmert/pdf/22665-Memmert-Whitepaper-Stability-Tests.pdf
STABILITY TESTING ACCORDING TO ICH Q1A (R2): BASICS AND TECHNICAL SOLUTIONS
...ICH guideline Q1A (R2) describes the require-ments for climate zones I and II. It combines climate zones I and II into one and defines them using the worst-case condition, i.e. 25 °C/60% RH....
https://www.helago-cz.com/files/binder/2024-02-whitepaper-ich-stability-testing-en.pdf
ICH Official web site : ICH
...ICH Official web site : ICH...
https://www.ich.org/fleadmin/public_web_site/ICH_Products/Guidelines/Quality/Q1A_R2_Guideline.pdf