ICH Q3A Impurities in New Drug Substances
E555141
ICH Q3A Impurities in New Drug Substances is an international regulatory guideline that sets quality standards and thresholds for identifying, reporting, and controlling impurities in new active pharmaceutical ingredients.
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf |
ICH quality guideline
ⓘ
pharmaceutical regulatory guideline ⓘ |
| abbreviation | ICH Q3A NERFINISHED ⓘ |
| addresses |
batch analysis for impurity profiling
ⓘ
specification setting for impurities ⓘ stability studies with respect to impurities ⓘ |
| aimsTo |
avoid unnecessary differences in impurity requirements between regions
ⓘ
provide a consistent approach to impurity control in new drug substances ⓘ |
| appliesDuring |
drug development
ⓘ
marketing authorisation applications ⓘ |
| appliesTo |
new active pharmaceutical ingredients
ⓘ
new drug substances ⓘ |
| basisFor | regulatory assessment of impurity specifications in new drug substance dossiers ⓘ |
| concerns |
quality impact of impurities
ⓘ
safety impact of impurities ⓘ |
| covers |
inorganic impurities
ⓘ
organic impurities ⓘ residual solvents ⓘ |
| defines |
requirements for identification of impurities
ⓘ
requirements for qualification of impurities ⓘ requirements for reporting of impurities ⓘ thresholds for identification of impurities ⓘ thresholds for qualification of impurities ⓘ thresholds for reporting of impurities ⓘ |
| documentType | scientific and technical guideline ⓘ |
| excludes | biotechnological and biological products ⓘ |
| focusesOn | impurities in new drug substances ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| language | English ⓘ |
| objective |
to ensure safety and quality of new active pharmaceutical ingredients
ⓘ
to harmonise impurity control requirements for new drug substances among ICH regions ⓘ |
| region |
European Union
NERFINISHED
ⓘ
Japan NERFINISHED ⓘ United States of America ⓘ
surface form:
United States
|
| regulatoryDomain |
drug substance quality
ⓘ
pharmaceutical quality ⓘ |
| relatedGuideline |
ICH Q3B Impurities in New Drug Products
NERFINISHED
ⓘ
ICH Q3C Impurities: Guideline for Residual Solvents NERFINISHED ⓘ |
| requires |
appropriate analytical procedures for impurity detection
ⓘ
justification of impurity limits ⓘ safety qualification of significant impurities ⓘ |
| targetAudience |
analytical chemists in pharmaceutical development
ⓘ
quality assurance professionals ⓘ regulatory affairs professionals ⓘ |
| usedBy |
pharmaceutical industry
ⓘ
regulatory authorities in ICH regions ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.