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Review Considerations on Additional Centers under an Approved License Rosia E. Nesbitt, BS, SBB(ASCP), CQA(ASQ) Consumer Safety Officer CBER, OBRR, DBA September 16, 2009. Outline. When to Submit Content of Submission Offsite Storage Facility Labels CBER Review of Supplement. When to Submit.

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Outline

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  1. Review Considerations onAdditional Centers under an Approved LicenseRosia E. Nesbitt, BS, SBB(ASCP), CQA(ASQ)Consumer Safety OfficerCBER, OBRR, DBASeptember 16, 2009

  2. Outline • When to Submit • Content of Submission • Offsite Storage Facility • Labels • CBER Review of Supplement

  3. When to Submit • After your “establishment is in operation and is manufacturing the complete product for which a biologics license is desired” [600.21] • We recommended that sufficient data is available for review during an inspection • We have observed that it is more efficient to submit the request to supplement your BLA when you are ready for a pre-approval inspection • After you ensure staff are following your SOPs and policies, and FDA requirements [600.10(b)]

  4. Content of Submission • Form FDA 356h • Reporting category – PAS under 601.12(b) • Name and address, telephone number of the new facility • Registration Number • U.S. license number additional center will be opening under

  5. Content of Submission(cont.) • Total number donations processed to date • Total number of trained staff in all job descriptions, i.e., physician substitute, plasma processors, quality staff • May reference previously approved SOPs, labels, physician substitute program (include approved reference numbers)

  6. Content of Submission (cont.) • Name of computer system, version number, and if it is 510(k) cleared • Name, address, registration number of contractors i.e., testing facility or facilities, offsite storage • Name of anticipated consignee with a statement that release of product to consignee will occur in accordance with established SOPs and regulations after approval of submission • Offsite storage facility Information

  7. Content of Submission(cont.) • Organizational chart with key personnel at plasma center • Major equipment (e.g., automated plasmapheresis instruments, walk-in freezers, etc.) • Description of equipment • Name, model number, and software version • Oversight of QA activities at center

  8. Labels • Submit if they contain specific facility addresses • Form FDA 2567

  9. CBER Review of Supplement • Desk review of the submission • Assign Submission Tracking Number • Review submitted information; communicate with applicant if needed • Schedule pre-approval inspection • Pre-approval inspection of the center • Complete desk review • Obtain a compliance status check of the center • Prepare review memo and approval letter; undergoes quality review • Approval letter mailed to applicant

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