WHO Stability Guidelines:
WHO has also formulated international regulatory standards on several quality related issues, which include stability, packaging, storage, and bioequivalence. Care must be taken to ensure that active pharmaceutical compounds remain stable and unaffected by packaging materials or storage conditions. Further, the establishment of bioequivalence standards between brand and generic drugs is of great importance given WHO’s support of generic products and their potential to increase access to essential drugs.
WHO Stability Links:
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”
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Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms Annex 5, WHO Technical Report Series 863, 1996
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Item 10.1 TRS 937:
Item 10.1, WHO Technical Report Series 937, 2006
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Update, Item 11.1 TRS 908
Item 11.1, WHO Technical Report Series 908, 2003
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Consultation of Stability studies in a global environment :
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