STABILITY: Guidelines

International Conference for Harmonization (ICH)

   Stability testing of active pharmaceutical ingredients and ﬁnished pharmaceutical products -
  WHO Technical Report Series, No. 953, 2009 - Annex 2

Draft regional guidelines on stability testing of active substances and pharmaceutical products
(Regional Committee for the Eastern Mediterranean)

  STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED
  PHARMACEUTICAL PRODUCTS

(Working document QAS/06.179/Rev.3)

European Medicines Agency (EMA)

(Scientific Guidelines on Stability)

Stability testing for applications for variations to a marketing authorization	Draft guideline Concept paper
Stability Testing for Applications for Variations to a Marketing Authorisation	Adopted guideline
Stability Testing of New Drug Substances and Drug Products (ICH Q1A (R2)).	Adopted guideline
Stability Testing of Existing Active Ingredients and Related Finished Products.	Adopted guideline
Annex: Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances	Adopted guideline
Evaluation of Stability Data (ICH Q1E)	Adopted guideline
Stability Data Package for Registration in Climatic Zones III and IV (ICH Q1F)	Adopted guideline
Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products (ICH Q1D)	Adopted guideline
In-Use Stability Testing of Human Medicinal Products	Adopted guideline
Maximum Shelf-Life for Sterile Products for Human Use after first opening or following Reconstitution	Adopted guideline
Photostability Testing of New Active Substances and Medicinal Products (ICH Q1B)	Adopted guideline
Stability Testing: Requirements for New Dosage Forms (ICH Q1C)	Adopted guideline

US Food and Drug Administration (USFDA)

Stability Testing of Drug Substances

and Drug Products

Health Canada

Stability Testing of Existing Drug Substances and Products

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