Triple

T22457542
Position Surface form Disambiguated ID Type / Status
Subject ICH Q11 Development and Manufacture of Drug Substances E555153 entity
Predicate relatedTo P37 FINISHED
Object ICH Q9 Quality Risk Management — NE NERFINISHED

How this triple was built (2 steps)

Every LLM step that produced this triple, in pipeline order — named-entity classification, the disambiguation choices (the exact options shown, with the pick highlighted), and the generated description. The batch + timestamp of each is in the Provenance table below.

NER Named-entity recognition gpt-5-mini
Instruction
Given a phrase, classify it is english named entity (e.g., persons, organizations, works of art) in Latin script, or not (e.g., literals, dates, URLs, verbose phrases). For disambiguation, the statement where the phrase occurs as object is also given. Please return a JSON object with `phrase` (string, the phrase being analyzed) and `is_ne` (boolean, indicating whether the phrase is a Named Entity).
Input
Phrase: ICH Q9 Quality Risk Management | Statement: [ICH Q11 Development and Manufacture of Drug Substances, relatedTo, ICH Q9 Quality Risk Management]
NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07 
Target entity: ICH Q9 Quality Risk Management
Context triple: [ICH Q11 Development and Manufacture of Drug Substances, relatedTo, ICH Q9 Quality Risk Management]
  • A. ICH Q9 Quality Risk Management chosen
    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.
  • B. ICH Q10 Pharmaceutical Quality System
    ICH Q10 Pharmaceutical Quality System is an international guideline that establishes a comprehensive, lifecycle-based framework for pharmaceutical quality management to ensure consistent product quality and regulatory compliance.
  • C. ICH Q8 Pharmaceutical Development
    ICH Q8 Pharmaceutical Development is an international guideline that outlines a systematic, science- and risk-based approach to pharmaceutical product and process development, forming a core part of the ICH quality framework.
  • D. ISO 14971
    ISO 14971 is an international standard that specifies a systematic process for risk management of medical devices throughout their life cycle.
  • E. ICH Q11 Development and Manufacture of Drug Substances
    ICH Q11 Development and Manufacture of Drug Substances is an ICH guideline that provides principles and expectations for the development and manufacturing of chemical and biotechnological drug substances within a quality-by-design framework.
  • F. None of above.
  • G. Unsure - the case is ambiguous/there is not enough information to decide.

Provenance (2 batches)

The batch behind each pipeline step, in order, with when it ran. Timestamps are batch-level — stages were processed in waves, so the object chain (NER → NED1 → NEDg → NED2) reads in order, but predicate / elicitation batches can sit in a different wave.

Step Stage Batch ID Status When
creating Elicitation batch_69e11e51fdec8190adfdf9f8a6362221 completed April 16, 2026, 5:37 p.m.
NER Named-entity recognition batch_69f15b7d00208190955a70e2c22d25a4 completed April 29, 2026, 1:14 a.m.
Created at: April 16, 2026, 8:48 p.m.