Stability

Stability Testing for Medicated Premixes
VICH GL8 (Quality - Stability premixes) November 1999 - Implemented in June 2001
Stability Testing: Requirements for New Dosage Forms
VICH GL4 Annex to the VICH guidelines on Stability Testing for New Drugs and Products (Quality - Stability) - Implemented in May 2000
Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)
VICH GL3(R) (Quality - Stability) – Implemented in January 2008
Stability Testing: Photostability Testing of New Drug Substances and Products
VICH GL5 (Quality - Stability) - Implemented in May 2000
Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products
VICH GL45 (Pharmaceuticals - Quality) - April 2010 - Implemented in April 2011
Statistical evaluation of stability data
VICH GL51 (Phramaceuticals - Quality: Stability Data) - February 2013 - Implemented in February 2014
Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
VICH GL58 (Quality - Stability) - November 2019 - for implementation at step 7 in the regions by November 2020

Guidelines