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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Review Memorandum - RiaSTAP

MEMORANDUM

To:File  (STN 125317/0)
 Company:CSL Behring GmbH
 Product:

Riastap
Fibrinogen Concentrate (Human), Pasteurized

From:

Donald A. Lebel (Committee Member)
CBER/OBRR/DH/Laboratory of Hemostasis (LH)

Through:

Timothy Lee, Ph.D.
Acting Laboratory Chief, CBER/OBRR/DH/LH

CC:

Laura Wood (Chairperson), CBER/OBRR/DH/LH

Pauline Cottrell
Regulatory Project Manager (RPM)
CBER/OBRR/DH/Division of Blood Applications (DBA)

Subject:

 Batch Record Evaluation as part of a BLA Review
Volume(s) 18 through 22

 Background/ Summary

This review is a result of a request by the Committee Chairperson to review and evaluate the acceptability of the batch record(s) within Volumes 18 through 22 of the listed Biologics License Application (BLA). The purpose of this evaluation and review is to determine if the batch record(s) and data included are accurate, and whether or not any mistakes or inconsistencies are noted, as well as to note any issues or inconsistencies that may need to be addressed. All of the Batch Records have been submitted in German. Due to the fact that the records are not in English, review of the records will include the following:

  • No blank spaces or lines requiring data/information
  • All items are properly signed and dated according to 21 CFR 211.186(a). “to assure uniformity from batch to batch, master production and control records for each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated and signed by a second person.”
  •  21 CFR 211.188 “Batch Records…shall included complete information relating to the production and control of each batch”). Records appear to be complete.

The purpose of this review is not to evaluate the acceptability of the viral assays/ testing and calculations or to make any determination as to the correctness of the data included in these sections. Those evaluations will be determined by other reviewers participating in this review specializing in those areas.

 

Manufacturing Process Summary

 

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Three (3) Pages determined to be not releasable: (b)(4)

 


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Review Comments

A complete review of the volumes listed above showed no inconsistencies in any of the documents reviewed. There are no questions and or comments.

Recommendation

The above mentioned documents appear to be acceptable. Final review and determination of acceptability is the responsibility of the Committee Chairperson.