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One of the most common failures cited by FDA inspectors in Warning Letters is the lack of adequate documentation. The FDA wants to see details on how firms make and keep written procedures for specifications, Quality Control operations, Master Manufacturing Records, returned goods and equipment.

More specifically, the FDA expects documentation to show that batches were properly made and that the quality control personnel performed their review and disposition of products at the time of manufacturing.

What’s in your Batch Production Records (BPR)?

According to cGMP requirements, here are 10 key measures that must be included in a BPR:

  1. The identity of the equipment and processing lines used in producing the batch
  2. The date and time of the maintenance, cleaning and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs
  3. The identity and weight or measure of each component and dietary ingredient used in the batch
  4. A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing
  5. Documentation that the finished dietary supplement meets its specifications
  6. A unique batch number for each batch
  7. Proof that quality control reviewed the BPR and dispositioned the batch
  8. All results which were obtained during the operation
  9. Reference to the physical location of the label
  10. Manufacturing steps for tablets and capsules to prevent metal or other foreign materials from equipment getting into the batch

Check out our compliance page for further reading on how InstantGMP electronic batch record and electronic device history record software reinforces Good Manufacturing Practices. Our workflows seamlessly implement GMP requirements with master records and batch production records to ensure quality during production.


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