A-A-0051910(DM)
1. Six (6) vials of globulin and diluents (including circulars) from each lot or batch, accompanied by a DD Form 1222 bearing the following information:
a. National Stock Number
b. Item Identification
c. Contract Number
d. Contractor’s name and address
e. Lot or control number
f. Quantity of material represented by the sample
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 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 the samples, directly to the Technical Operations Division, Directorate of Medical Material, Defense Personnel Support Center, ATTN: DPSC-RSQ, 2800 South 20th Street, Philadelphia, PA 19101.
When inspection is made at designation, 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 product shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing a single-dose vial of Globulin, Rho(D) Immune, and a single-dose container containing sufficient Sterile Water for Injection, USP to permit reconstitution of sterile powder. One package containing 6 packages, as specified, constitutes one unit.
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