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A collection of closed, final containers or other final dosage units that are expected to be homogeneous and equivalent with respect to risk of contamination during filling or preparation of the final product. The dosage units are filled, or otherwise prepared, from the same bulk vaccine, freeze-dried together (if applicable) and closed in one continuous working session. They bear a distinctive number or code identifying the final lot (batch). Where a final bulk vaccine is filled and/or freeze-dried on several separate sessions, there results a related set of final lots (batches) that are usually identified by the use of a common part in the distinctive number or code; these related final lots (batches) are sometimes referred to as sub-batches, sub-lots or filling lots.
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