English to Russian Medical Medical: Pharmaceuticals

Batch Records
2.3.1 Batch Number Assignation and Batch Record Contents
Information associated with the production and testing of a particular batch is
compiled in a batch file or batch record, which includes documentation of
manufacturing process and QC test results. Controlled documents describes batch
number assignation and the numbers used to designate different product types.
Batch records are reviewed for completeness and assurance that all manufacturing
instructions were followed, and that all test results (from in-process control and QC
lab tests) are within acceptance criteria. When completed, the batch file is
inspected, signed and approved for release by QA department personnel.