Batch Record

Example Definitions of "Batch Record"
Batch Record. Shall mean a batch manufacturing record, prepared according to applicable cGMP guidelines, for every production batch of API.
Batch Record. Shall 1.4. "Batch Record" shall mean a batch manufacturing record, prepared according to applicable cGMP guidelines, for every production batch of API.
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Batch Record. The document created as and after each Batch is Processed and Packaged. Each Batch Record shall reflect and incorporate all aspects of the Master Batch Record, the applicable Certificate of Analysis, and any Manufacturing Variance Reports issued with respect to such Batch
Batch Record. The specific documentation produced in connection with the Manufacture of a particular Batch and/or lot.
Batch Record. An accurate reproduction of the Master Batch Record documenting each significant step in the manufacturing, processing, testing, packaging and/or holding of a particular Batch.
Batch Record. (also referred to as Manufacturing Batch Record (MBR) or Batch Production Record (BPR) means a manufacturing record for a Batch generated by Gallus concurrently with the performance of each step of the production of a specific Batch or Lot of material such that successive steps in such processes may be traced.
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