Division of Biological Standards and Quality Control (DBSQC)

Develops product testing programs in a secured and controlled environment using appropriately qualified and validated methods for generating data supportive of Center regulatory activities.
Maintains product testing programs in a manner that meets internationally recognized standards.
Participates in lot release activities by performing testing of submitted samples and review of lot release protocols according to approved testing programs.
Participates in regulatory review activities by contributing expertise to the evaluation of test methods, assessment of acceptability of assay method validation packages, and evaluation of appropriateness of product specifications.
Prepares, calibrates, holds and distributes official U.S. reference preparations used in the control testing of biological products.
Develops and maintains scientific programs for the evaluation and standardization of reagent test kits and related devices in cooperation with other Center components.

Major responsibilities of the Laboratory of Analytical Chemistry and Blood Related Products include:

Evaluates product samples submitted in support of INDs, license applications and supplements for evaluation and lot release, or for special post-marketing surveillance.
Performs review of manufacturer’s lot release protocols.
Facilitates the development of post license product lot release Testing Plans, and guides the form and content of lot release protocols.
Performs review of INDs, BLAs and supplements as necessary to support other Center components.
Cooperates with other Agency components in the review of medical devices related to infectious disease testing when such products have label indications for use in blood establishments, and evaluates and validates lot release Serum panels.

Major responsibilities of the Quality Assurance Branch include:

Provides support for development and maintenance of programs proscribed by the elements of DBSQC’s Quality Program and as required by appropriate quality standard(s).
Manages document and record control and tracking of submitted regulatory samples within the laboratory.
Audits laboratory reports and laboratory functions as required to assure compliance with requirements of operating quality system.

Major responsibilities of the Laboratory of Microbiology, In-Vivo Testing and Standards include:

Evaluates product samples submitted in support of INDs, license applications and supplements for evaluation and lot release, or for special post-marketing surveillance.
Performs review of manufacturer’s lot release protocols.
Coordinates the technology transfer of significant new testing capabilities into the unit from both internal and external sources and completes required qualification and validation studies.
Facilitates the development of post license product lot release Testing Plans, and guides the form and content of lot release protocols.
Performs review of INDs, BLAs and supplements as necessary to support other Center components.
Evaluates and develops new assay technologies that relate directly to the DBSQC mission.

Additional information about DBSQC's responsibilities is available in FDA’s Staff Manual Guide.

U.S. Food and Drug Administration