ICH Q9 Quality Risk Management
E131968
ICH Q9 Quality Risk Management is an international guideline that provides a systematic, science- and risk-based approach to identifying, evaluating, and controlling quality risks throughout the lifecycle of pharmaceutical products.
All labels observed (4)
| Label | Occurrences |
|---|---|
| ICH Q9 Quality Risk Management canonical | 6 |
| ICH Q9 | 1 |
| ICH Q9(R1) | 1 |
| International Council for Harmonisation Guideline Q9: Quality Risk Management | 1 |
Statements (62)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
pharmaceutical quality guideline ⓘ regulatory guidance document ⓘ |
| aimsTo |
enhance patient protection
ⓘ
facilitate continual improvement ⓘ improve quality assurance ⓘ support regulatory decision making ⓘ |
| appliesLifecycleStage |
commercial manufacturing phase
ⓘ
pharmaceutical development phase ⓘ product discontinuation phase ⓘ technology transfer phase ⓘ |
| appliesTo |
drug development
ⓘ
pharmaceutical manufacturing ⓘ pharmaceutical products ⓘ pharmaceutical quality systems ⓘ |
| describesApproach |
lifecycle approach to quality
ⓘ
risk-based decision making ⓘ science-based quality risk management ⓘ |
| documentType | harmonised tripartite guideline ⓘ |
| firstAdopted | 2005 ⓘ |
| focusesOn |
quality risk management
ⓘ
risk communication ⓘ risk control ⓘ risk review ⓘ systematic risk assessment ⓘ |
| fullName |
ICH Q9 Quality Risk Management
self-linksurface differs
ⓘ
surface form:
International Council for Harmonisation Guideline Q9: Quality Risk Management
|
| hasAbbreviation |
ICH Q9 Quality Risk Management
self-linksurface differs
ⓘ
surface form:
ICH Q9
|
| hasRevision |
ICH Q9 Quality Risk Management
self-linksurface differs
ⓘ
surface form:
ICH Q9(R1)
|
| includesConcept |
risk analysis
ⓘ
risk communication ⓘ risk control ⓘ risk evaluation ⓘ risk identification ⓘ risk review ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ⓘ |
| language | English ⓘ |
| mentionsTool |
Six Sigma
ⓘ
surface form:
FMEA
FMECA ⓘ Failure Mode and Effects Analysis ⓘ Fault Tree Analysis ⓘ Hazard Analysis and Critical Control Point ⓘ
surface form:
HACCP
HAZOP ⓘ Hazard Analysis and Critical Control Point ⓘ
surface form:
Hazard Analysis and Critical Control Points
Hazard Operability Analysis ⓘ risk ranking and filtering ⓘ supporting statistical tools ⓘ |
| recommends | use of formal risk assessment tools ⓘ |
| regionallyImplementedBy |
European Medicines Agency
ⓘ
Pharmaceuticals and Medical Devices Agency Japan ⓘ Food and Drug Administration ⓘ
surface form:
U.S. Food and Drug Administration
|
| relatedTo |
Good Manufacturing Practice
ⓘ
pharmaceutical quality system ⓘ |
| revisionAdopted | 2020s ⓘ |
| shortIssuer | ICH ⓘ |
| supports |
ICH Q10 Pharmaceutical Quality System
ⓘ
ICH Q11 Development and Manufacture of Drug Substances ⓘ ICH Q8 Pharmaceutical Development ⓘ |
| usedFor |
analysis of quality risks
ⓘ
control of quality risks ⓘ evaluation of quality risks ⓘ identification of quality risks ⓘ review of quality risks ⓘ |
Referenced by (9)
Full triples — surface form annotated when it differs from this entity's canonical label.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
→
notableWork
→
ICH Q9 Quality Risk Management
ⓘ
ICH Q9 Quality Risk Management
→
hasAbbreviation
→
ICH Q9 Quality Risk Management
self-linksurface differs
ⓘ
this entity surface form:
ICH Q9
ICH Q9 Quality Risk Management
→
fullName
→
ICH Q9 Quality Risk Management
self-linksurface differs
ⓘ
this entity surface form:
International Council for Harmonisation Guideline Q9: Quality Risk Management
ICH Q9 Quality Risk Management
→
hasRevision
→
ICH Q9 Quality Risk Management
self-linksurface differs
ⓘ
this entity surface form:
ICH Q9(R1)