A-A-0053047 Globulin, Hepatitis B Immune, Usp

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A-A-0053047(DM)

2. One (1) copy of the protocol which the manufacturer has submitted to the Office of Biologics Research and Review (OBRR) stating the essential manufacturing processes and results of tests for each lot or batch.

3. One (1) copy of Office of Biologics Research and Review (OBRR) release for each lot or batch.

Shipment of material shall not be withheld for a report from Walter Reed Army Institute of Research.

When inspection is made at source, the quality assurance representative shall submit one (1) copy of the Office of Biologics Research and Review (OBRR) release and certificate of sterility for each lot or batch, and two (2) copies of document, submitted with samples, directly to the Technical Operations Division, Directorate of Medical Material, Defense Personnel Support Center, ATTN: DPSC-RSQ, 2800 South 20^th Street, Philadelphia, PA 19101.

When inspection is made at destination, the contractor shall submit one (1) copy of the Office of Biologics Research and Review (OBRR) release and certificate of sterility for each lot or batch, and two (2) copies of document submitted with samples, directly to the Defense Personnel Support Center, addresses as shown above, and one (1) copy of the Office of Biologics Research and Review (OBRR) release shall also be forwarded with the shipment to the consignee.

Workmanship. The Vials shall be free from defects which detract from each appearance or impair their serviceability.

Unit. Vial (VI). One vial containing 5 ml, as specified, constitutes one unit.

Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.