Guidelines

Find out more on guidelines

Guideline Links
EMEA http://www.emea.eu.int
FDA http://www.guidelines.gov
NICE http://www.nice.org.uk
 
ICH Harmonised Triparite Guideline Downloads
Stability testing of new Drug Substances and Products Q1A(R2) Download Q1A(R2)
Photostability testing of new Drug Substances and Products Q1B Download Q1B
Bracketing and Matrixing Designs for Stabiliy Testing of new Drug Substances and Products Q1D Download Q1D
Evaluation for Stability Data Q1E Download Q1E
Quality of bBiotechnoloical Products: Stabiliy Testing of Biotechnological/Biological Products Q5C Download Q5C
 
Guidance for Industry Downloads
Stability testing of new Veterinary Drug Substances and Medicinal Products (Revision) VICH GL3(R) Download VICH GL3(R)
Stability testing of new Veterinary Dosage Forms Download VICH GL4
Stability testing: Photostability testing of new Veterinary Drug Substances and Medicinal Products VICH GL5 Download VICH GL5
Stability testing for Medicated Premixes VICH GL8 Download VICH GL8