Office of Compliance and Biologics Quality
E409912
The Office of Compliance and Biologics Quality is a division within the FDA’s biologics center responsible for ensuring the safety, quality, and regulatory compliance of biological products such as vaccines, blood, and cellular therapies.
All labels observed (2)
How this entity was disambiguated
This entity first appeared as the object of triple T4061239 — 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: Office of Compliance and Biologics Quality Context triple: [Center for Biologics Evaluation and Research, hasDivision, Office of Compliance and Biologics Quality]
-
A.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is the U.S. regulatory body responsible for overseeing the safety, efficacy, and quality of biological products such as vaccines, blood products, and gene therapies.
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B.
Office of Pharmaceutical Quality
The Office of Pharmaceutical Quality is a U.S. Food and Drug Administration office responsible for ensuring the quality, safety, and consistency of human drugs throughout their lifecycle.
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C.
Office of Regulatory Affairs
The Office of Regulatory Affairs is the U.S. FDA’s primary field organization responsible for inspecting regulated products and manufacturers, enforcing compliance, and overseeing import operations to protect public health.
-
D.
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is the U.S. FDA division responsible for overseeing the safety, effectiveness, and quality of prescription and over-the-counter drugs.
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E.
Office of Quality and Compliance
The Office of Quality and Compliance is a division within the Oregon Department of Human Services responsible for overseeing adherence to standards, regulations, and best practices to ensure effective and accountable delivery of human services.
- 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: Office of Compliance and Biologics Quality Target entity description: The Office of Compliance and Biologics Quality is a division within the FDA’s biologics center responsible for ensuring the safety, quality, and regulatory compliance of biological products such as vaccines, blood, and cellular therapies.
-
A.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is the U.S. regulatory body responsible for overseeing the safety, efficacy, and quality of biological products such as vaccines, blood products, and gene therapies.
-
B.
Office of Pharmaceutical Quality
The Office of Pharmaceutical Quality is a U.S. Food and Drug Administration office responsible for ensuring the quality, safety, and consistency of human drugs throughout their lifecycle.
-
C.
Office of Regulatory Affairs
The Office of Regulatory Affairs is the U.S. FDA’s primary field organization responsible for inspecting regulated products and manufacturers, enforcing compliance, and overseeing import operations to protect public health.
-
D.
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is the U.S. FDA division responsible for overseeing the safety, effectiveness, and quality of prescription and over-the-counter drugs.
-
E.
Office of Quality and Compliance
The Office of Quality and Compliance is a division within the Oregon Department of Human Services responsible for overseeing adherence to standards, regulations, and best practices to ensure effective and accountable delivery of human services.
- F. None of above. chosen
Statements (46)
| Predicate | Object |
|---|---|
| instanceOf |
division of a government agency
ⓘ
office ⓘ regulatory office ⓘ |
| abbreviation | OCBQ ⓘ |
| collaboratesWith |
Office of Regulatory Affairs
ⓘ
other FDA centers ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| field |
biologics regulation
ⓘ
public health ⓘ quality assurance ⓘ regulatory compliance ⓘ |
| function |
enforcement of FDA regulations for biologics
ⓘ
inspection of biologics manufacturing facilities ⓘ oversight of manufacturing practices for biologics ⓘ policy development related to biologics quality and compliance ⓘ post-market surveillance of biologic products for compliance issues ⓘ review of biologics license applications for compliance aspects ⓘ |
| goal |
ensure that biological products are potent
ⓘ
ensure that biological products are pure ⓘ ensure that biological products are safe ⓘ protect public health ⓘ |
| hasSubUnit |
Division of Biological Standards and Quality Control
ⓘ
Division of Case Management ⓘ Division of Inspections and Surveillance ⓘ Division of Manufacturing and Product Quality ⓘ |
| jurisdiction |
United States government
ⓘ
surface form:
United States federal government
|
| locatedIn | Silver Spring, Maryland ⓘ |
| oversees |
biologics quality systems and controls
ⓘ
implementation of current good manufacturing practice for biologics ⓘ |
| parentOrganization |
Center for Biologics Evaluation and Research
ⓘ
Food and Drug Administration ⓘ
surface form:
U.S. Food and Drug Administration
|
| partOf | Center for Biologics Evaluation and Research ⓘ |
| regulates |
blood products
ⓘ
cellular therapies ⓘ certain medical devices related to biologics ⓘ gene therapy products ⓘ plasma-derived products ⓘ tissue-based products ⓘ vaccines ⓘ |
| responsibleFor |
quality of biological products
ⓘ
regulatory compliance of biological products ⓘ safety of biological products ⓘ |
| supervises | compliance programs for biologics manufacturers ⓘ |
| usesRegulatoryAuthorityFrom |
Federal Food, Drug, and Cosmetic Act
ⓘ
Public Health Service Act ⓘ |
| website |
Office of Compliance and Biologics Quality
self-linksurface differs
ⓘ
surface form:
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/office-compliance-and-biologics-quality
|
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: Office of Compliance and Biologics Quality Description of subject: The Office of Compliance and Biologics Quality is a division within the FDA’s biologics center responsible for ensuring the safety, quality, and regulatory compliance of biological products such as vaccines, blood, and cellular therapies.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
Center for Biologics Evaluation and Research
→
hasDivision
→
Office of Compliance and Biologics Quality
ⓘ
Office of Compliance and Biologics Quality
→
website
→
Office of Compliance and Biologics Quality
self-linksurface differs
ⓘ
this entity surface form:
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/office-compliance-and-biologics-quality