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7.4: Office of Compliance & Biologics Quality (OCBQ)

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    Preapproval Inspections for Biologics

    Part of the BLA process includes a pre-license inspection, as outlined in the CFR. The inspector is looking for all the related operation facilities during all phases of manufacturing. These checks typically happen about halfway through the review cycle. The Division of Manufacturing and Product Quality in CBER's Office of Compliance and Biologics Quality (OCBQ) are responsible for the inspections of biologic drugs and devices. The Division of Blood Applications in CBERS OBRR is the lead for blood and blood product applicant inspections.

    Office of Compliance & Biologics Quality Activities

    The compliance activities related to biologics are customarily overseen by CBER's Office of Compliance & Biologics Quality (OCBQ). The OCBQ has many important activities within CBER and the approval of a biologic, including inspection and compliance activities, pre- and post-market approval activities, and compliance. It's important to note here that the FDA has limited recall authority – and recall of biologic products is voluntary. If CBER identifies areas of noncompliance it may issue a Regulatory Action Letter, revocate the BLA that has been published on that product (or even other products from the same company/facility), seizure, and injunction as well. More on FDA enforcement in a later chapter. Below is an overview of the compliance activities of the OCBQ. This excerpt is from the OCBQ website: https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ucm331317.htm

    OCBQ Inspection, Surveillance, and Compliance Activities

    • Ensures the quality of products regulated by CBER over their entire lifecycle through pre-market review and inspection, and post-market review, surveillance, inspection, outreach, and compliance.
    • Monitors the quality of marketed biological products through surveillance, inspections, and compliance programs; reviews, evaluates and takes appropriate compliance action
    • Reviews and evaluates all administrative action recommendations including suspension, revocation, denial of a license, disqualification of investigators, and recommended civil and criminal actions, including seizures, injunctions, and prosecution based on findings of inspections and investigations
    • Directs the biologic product shortages program for CBER-regulated products.
    • Directs the recall program for CBER-regulated products.
    • Directs CBER's bioresearch monitoring program, and takes appropriate compliance actions
    • Biological Product Deviation and Blood Collection and Transfusion Related Fatality Reports

    OCBQ Pre- and Post-Market Approval Activities

    • Leads pre-approval and pre-license inspections
    • Provides assessment of the compliance status of regulated establishments within CBER's purview
    • Evaluates proposed proprietary names to avoid potential medication errors related to look-alike and proprietary sound-alike names and mitigating other factors that contribute to medication errors
    • Provides consultative reviews of proposed product labeling
    • Plans and conducts tests on biological products and conducts research to develop and improve procedures to evaluate the safety, efficacy, and purity of biological products
    • In cooperation with other Center components, as appropriate, tests biological products submitted for release by manufacturers

    Compliance-Related Policy Activities

    • Advises the Center Director and other Agency officials on emerging and significant compliance issues for biological products and serves as CBER's focal point for surveillance and enforcement policy
    • Develops, with other CBER/Agency components, policies and compliance standards for biological products, including Current Good Manufacturing Practice (CGMP) regulations; ensures the uniform interpretation of standards and evaluates industry's conformance with CGMP in manufacturing biological products

    This page titled 7.4: Office of Compliance & Biologics Quality (OCBQ) is shared under a CC BY license and was authored, remixed, and/or curated by Jack O'Grady.

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