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Review Considerations onAdditional Centers under an

Approved License Rosia E. Nesbitt, BS, SBB(ASCP), CQA(ASQ)

Consumer Safety OfficerCBER, OBRR, DBASeptember 16, 2009

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Outline• When to Submit

• Content of Submission

– Offsite Storage Facility

– Labels

• CBER Review of Supplement

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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)]

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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

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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)

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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

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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

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Labels• Submit if they contain specific facility

addresses

• Form FDA 2567

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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