Batch Production Record Log and Batch Adjustment Log

Manufacturing – MMR and BPR (Parts H & I)

Batch Production Record Log and Batch Adjustment Log

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Published: Monday, October 17, 2016

This batch production record log can be used to document the issuance of batch production records. In this example, the log also includes columns to record the issuance of bulk labels printed by QA for each batch. (Issuance of purchased labels or retail labels would need different documentation.) Due to the critical nature of batch production records, this log should preferably be kept in a bound notebook or accounting ledger rather than on loose-leaf pages.

The batch adjustment log can be used to track machine adjustments made during the run of a batch (especially for unit dosing operations such as encapsulation or tableting).This information is not necessarily required by GMPs but can be useful in finding the optimal machine settings for the product, for future reference. The information can also help isolate problematic sections of the batch which may, for example, require inspection or sorting, especially if the adjustment times can be correlated to the output container numbers produced sequentially during dosing (this generally requires the container start and/or finish times to be recorded in the batch production record). Note that the MMR or SOPs for the applicable process step must clearly delineate which types or ranges of in-process adjustments are pre-approved as part of the MMR or SOP vs. those which require QA approval on a case-by-case basis.

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