The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
Q1A – Q1F Stability Testings Download below
- Q1A(R2)Stability Testing of New Drug Substances and Products Q1A(R2)
- Q1BStability Testing : Photostability Testing of New Drug Substances and Products
- Q1CStability Testing for New Dosage Forms
- Q1DBracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
- Q1EEvaluation of Stability Data
- Q1FStability Data Package for Registration Applications in Climatic Zones III and IVFor downloads links Step4 Q1B Step4 Q1C Step4 Q1D Step4 Q1E Step4 or http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
