Guidelines
Quality
Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances + Decision Trees
VICH GL39 (Pharmaceuticals - Quality) November 2005 - Implemented in November 2006
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
Statistical evaluation of stability data
VICH GL51 (Phramaceuticals - Quality: Stability Data) - February 2013 - Implemented in February 2014
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
Stability Testing: Photostability Testing of New Drug Substances and Products
VICH GL5 (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: 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 for Medicated Premixes
VICH GL8 (Quality - Stability premixes) November 1999 - Implemented in June 2001
Validation of analytical procedures : Definition and Terminology
VICH GL1 (Validation definitions) - Implemented in October 1999
Validation of analytical procedures : Methodology
VICH GL2 (Validation methods) - Implemented in October 1999
Impurities: Residual Solvents in new Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
Revised VICH GL18 (R2) Revised VICH GL18 (R2) (Quality) - April 2023 - For implementation at step 7 in the regions by April 2024
Impurities in New Veterinary Medicinal Products (Revision)
VICH GL11(R) (Quality - Impurities Substances) – Implemented in January 2008
Impurities in New Veterinary Drug Substances (Revision)
VICH GL10(R) (Quality - Impurities Substances) – Implemented in January 2008