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current Good Analytical Laboratory Practices (cGALP)

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Stability Guidelines
 
ICH

Quality Guidelines : (Stability)

Q1A(R2): Stability Testing of New Drug Substances and Products 

Q1B: Photostability Testing of New Drug Substances and Products

Q1C: Stability Testing for New Dosage Forms

Q1D: Bracketing & Matrixing Designs for Stability Testing of Drug Substances & Drug Products

Q1E: Evaluation of Stability Data


WHO

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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Stability testing of active pharmaceuticals ingredients and finished pharmaceuticals products - Annex 2
WHO Technical Report Series 953, 2009
 
Consultation of Stability studies in a global environment
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USFDA
 

EMEA
 
Stability testing of new drug substances and products

TGA
 
Australian Regulatory Guidelines for Complementary Medicines(ARGCM)
 
TGA : Questions & answers on the stability testing of Listed complementary medicines

ASEAN
 
Stability study of drug product

GCC
 
Stability testing of drug substances and pharmaceutical products