Office of Compliance and Biologics Quality

E409912

division of a government agency office regulatory office

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.

Try in SPARQL Jump to: Surface forms Statements Referenced by

All labels observed (2)

Label	Occurrences
Office of Compliance and Biologics Quality canonical	1
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/office-compliance-and-biologics-quality	1

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

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