E-DRUG:Stability testing in a global environment (3)
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Dear Colleagues,
for information regarding stability testing conditions on a global level
you will find ample information on the WHO web site:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/regu
latory_standards/en/index.html
--> Stability
- Stability Testing of Pharmaceutical Products in a Global Environment
Dr Sabine Kopp reports on the development of World Health Organization
policy on stability testing.
"Article from The Regulatory Affairs Journal"
- Guidelines for stability testing of pharmaceutical products containing
well established drug substances in conventional dosage forms
Annex 5, WHO Technical Report Series 863, 1996
Update, Item 11.1, WHO Technical Report Series 908, 2003
Update Item 10.1, WHO Technical Report Series 937, 2006
- Report of a Consultation of Stability studies in a global environment
organized by WHO
WHO Medicines Quality Assurance website:
http://www.who.int/medicines/areas/quality_safety/quality_assurance
With best regards,
Dr Sabine Kopp
Quality Assurance & Safety: Medicines
World Health Organization
20, av. Appia
CH-1211 Geneva 27
Fax: +41 22 791 4730
"Kopp, Sabine" <kopps@who.int>