Vaccines, Blood & Biologics
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SOPP 8408.1: Development of Testing Plans and Release of Lots as Part of the Approval Process Appendix 1: flow chart: CBER Testing In Support of approval of the submission(DOC - 64KB)
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OCBQ/DMPQ/Product Release Branch
CBER’s Sample Custodian will be moving to FDA’s White Oak Campus: Building 75, Room G707 (ground floor)
CBER’s Sample Custodian (the person(s) responsible for receiving official lot release samples) is scheduled to move on Monday, August 11th, 2014.
The initial announcement of CBER’s move to the FDA White Oak campus was published in the Federal Register on March 5, 2014 (79 FR 12506). Additional information on several topics is provided on the CBER Move page available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
Lot Release Samples: UPDATED INFORMATION
CBER’s Sample Custodian (the person(s) responsible for receiving official lot release samples) is scheduled to move to the FDA White Oak campus in Silver Spring, Maryland on Monday, August 11, 2014. Due to unforeseen circumstances, receipt of lot release samples at the new White Oak campus has been delayed until Tuesday, September 2, 2014. This extended pause will allow us to ensure the orderly transfer of lot release samples to the FDA White Oak campus in the weeks immediately before and after the move. Therefore, lot release samples should be shipped to CBER for receipt after September 2, 2014, using the new address (see below).
New Sample Custodian Address at White Oak Campus
Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Lot Release Protocols
The receipt of lot release protocols will continue during the move to the FDA White Oak campus in Silver Spring, Maryland.
- Electronic lot release protocols submitted through the FDA Gateway will not be impacted by the move and may continue to be submitted at any time.
- Beginning August 11, 2014, lot release protocols submitted in paper or CD-ROM electronic format should be sent to the new CBER Sample Custodian address.
UPDATED INFORMATION: If lot release protocols are submitted during the lot release sample pause period (through September 2, 2014) without the required lot release samples, those lot release samples may be sent to the Sample Custodian any time after September 2, 2014 to the new address listed above.
- If commercial carriers are used, manufacturers should arrange for prepaid delivery directly to the CBER Sample Custodian using the new address.
- Staff names should NOT be placed on the document address. Addressing documents to individual staff members will result in a delay in CBER receiving the documents, and a delay in processing.
- The CBER Sample Custodian is available to accept lot release samples from 8:00 am to 3:30 pm (Eastern time), so deliveries should be scheduled accordingly.
The Product Release Branch recommends the following resources for manufacturers.
Frequently Requested Federal Register Notices
- FR Notice, Vol. 58, No. 137, July 20, 1993: Guidance on Alternatives to Lot Release for Licensed Biological Products
- FR Notice, Vol. 60, No. 236, December 8, 1995: Interim Definition and Elimination of Lot-by-Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products