Effective Batch Record Review Practices

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.  The WHO Guideline states that production and control records should be reviewed and any failure of a batch to meet its specifications should be thoroughly investigated.  The investigation should, if necessary, extend to other batches of the same product and other products that may have been associated with the specific failure.  A written record of the investigation should include the conclusion and follow up action.