ICH Q1 Stability Testing of New Drug Substances and Products
E555140
ICH Q1 Stability Testing of New Drug Substances and Products is an international regulatory guideline that defines the scientific principles and study requirements for assessing the stability, shelf life, and storage conditions of new pharmaceutical substances and finished products.
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
pharmaceutical stability guideline ⓘ regulatory guideline ⓘ |
| abbreviatedAs | ICH Q1 NERFINISHED ⓘ |
| aimsTo |
ensure quality of pharmaceutical products over shelf life
ⓘ
harmonise stability testing requirements among ICH regions ⓘ support assignment of expiration dates for drug products ⓘ support assignment of retest periods for drug substances ⓘ |
| appliesIn |
European Union
NERFINISHED
ⓘ
Japan NERFINISHED ⓘ United States NERFINISHED ⓘ |
| appliesTo |
marketed pharmaceutical products with significant changes
ⓘ
new chemical entities ⓘ new drug products ⓘ |
| covers |
evaluation and extrapolation of stability data
ⓘ
relative humidity conditions for stability studies ⓘ requirements for stability testing after packaging changes ⓘ temperature conditions for stability studies ⓘ |
| defines |
requirements for accelerated stability studies
ⓘ
requirements for intermediate stability studies ⓘ requirements for long-term stability studies ⓘ requirements for shelf life estimation ⓘ requirements for stability study design ⓘ requirements for stability testing of drug products in proposed container-closure systems ⓘ requirements for stability-indicating analytical methods ⓘ requirements for storage condition assignment ⓘ requirements for stress testing of drug substances ⓘ requirements for testing frequency in stability studies ⓘ |
| hasPart |
ICH Q1A(R2)
NERFINISHED
ⓘ
ICH Q1B NERFINISHED ⓘ ICH Q1C NERFINISHED ⓘ ICH Q1D NERFINISHED ⓘ ICH Q1E NERFINISHED ⓘ ICH Q1F NERFINISHED ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| language | English ⓘ |
| regulates |
stability testing of new drug products
ⓘ
stability testing of new drug substances ⓘ |
| relatedTo |
Good Manufacturing Practice
NERFINISHED
ⓘ
pharmaceutical quality by design ⓘ |
| subjectOf |
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
NERFINISHED
ⓘ
ICH Q1B: Photostability Testing of New Drug Substances and Products NERFINISHED ⓘ ICH Q1C: Stability Testing for New Dosage Forms NERFINISHED ⓘ ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products NERFINISHED ⓘ ICH Q1E: Evaluation of Stability Data NERFINISHED ⓘ ICH Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV NERFINISHED ⓘ |
| usedBy |
pharmaceutical companies
ⓘ
regulatory authorities in ICH regions ⓘ |
Referenced by (1)
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