Triple

T5932449
Position Surface form Disambiguated ID Type / Status
Subject ICH Q9 Quality Risk Management E131968 entity
Predicate supports P516 FINISHED
Object ICH Q11 Development and Manufacture of Drug Substances E555153 NE FINISHED

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 Q11 Development and Manufacture of Drug Substances | Statement: [ICH Q9 Quality Risk Management, supports, ICH Q11 Development and Manufacture of Drug Substances]
NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07 
Target entity: ICH Q11 Development and Manufacture of Drug Substances
Context triple: [ICH Q9 Quality Risk Management, supports, ICH Q11 Development and Manufacture of Drug Substances]
  • A. ICH Q11 Development and Manufacture of Drug Substances chosen
    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.
  • B. ICH Q3A Impurities in New Drug Substances
    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.
  • 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. 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.
  • E. ICH Q1 Stability Testing of New Drug Substances and Products
    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.
  • F. None of above.
  • G. Unsure - the case is ambiguous/there is not enough information to decide.

Provenance (3 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_69c0085b75e88190a632f9691f9da48b completed March 22, 2026, 3:18 p.m.
NER Named-entity recognition batch_69c0389df18c81909027a9db7596f0c1 completed March 22, 2026, 6:44 p.m.
NED1 Entity disambiguation (via context triple) batch_69c0e3affd748190a37e3cc60e58d6a6 completed March 23, 2026, 6:54 a.m.
Created at: March 22, 2026, 4 p.m.