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 | 7 |
| ICH Q9 | 1 |
| ICH Q9(R1) | 1 |
| International Council for Harmonisation Guideline Q9: Quality Risk Management | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T1151205 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: ICH Q9 Quality Risk Management Context triple: [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, notableWork, ICH Q9 Quality Risk Management]
-
A.
ISO 14971
ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
-
B.
ISO 13485
ISO 13485 is an international quality management standard that specifies requirements for organizations involved in the design, production, installation, and servicing of medical devices and related services.
-
C.
ISO 9000 family
The ISO 9000 family is a set of international standards that provide guidelines and requirements for establishing, implementing, and improving quality management systems in organizations.
-
D.
ISO 9001
ISO 9001 is an internationally recognized standard that specifies requirements for quality management systems to help organizations consistently meet customer and regulatory requirements.
-
E.
ISO 31010
ISO 31010 is an international standard that provides guidelines and a comprehensive toolkit of techniques for risk assessment within risk management frameworks.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: ICH Q9 Quality Risk Management Target entity description: 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.
-
A.
ISO 14971
ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
-
B.
ISO 13485
ISO 13485 is an international quality management standard that specifies requirements for organizations involved in the design, production, installation, and servicing of medical devices and related services.
-
C.
ISO 9000 family
The ISO 9000 family is a set of international standards that provide guidelines and requirements for establishing, implementing, and improving quality management systems in organizations.
-
D.
ISO 9001
ISO 9001 is an internationally recognized standard that specifies requirements for quality management systems to help organizations consistently meet customer and regulatory requirements.
-
E.
ISO 31010
ISO 31010 is an international standard that provides guidelines and a comprehensive toolkit of techniques for risk assessment within risk management frameworks.
- F. None of above. chosen
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 |
International Council for Harmonisation Guideline Q9: Quality Risk Management
ⓘ
linked to:
ICH Q9 Quality Risk Management
|
| hasAbbreviation |
ICH Q9
ⓘ
linked to:
ICH Q9 Quality Risk Management
|
| hasRevision |
ICH Q9(R1)
ⓘ
linked to:
ICH Q9 Quality Risk Management
|
| 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 |
FMEA
ⓘ
linked to:
Six Sigma
FMECA ⓘ Failure Mode and Effects Analysis ⓘ Fault Tree Analysis ⓘ HACCP ⓘ
linked to:
Hazard Analysis and Critical Control Point
HAZOP ⓘ Hazard Analysis and Critical Control Points ⓘ
linked to:
Hazard Analysis and Critical Control Point
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 ⓘ U.S. Food and Drug Administration ⓘ
linked to:
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 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: ICH Q9 Quality Risk Management Description of subject: 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.
Referenced by (10)
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
ⓘ
linked to: ICH Q9 Quality Risk Management
ICH Q9 Quality Risk Management
→
fullName
→
International Council for Harmonisation Guideline Q9: Quality Risk Management
ⓘ
linked to: ICH Q9 Quality Risk Management
linked to: ICH Q9 Quality Risk Management
ICH Q11 Development and Manufacture of Drug Substances
→
relatedTo
→
ICH Q9 Quality Risk Management
ⓘ