The Quality Assurance (QA) unit cannot release a batch for sale until the BPR is reviewed and finalized. The record must demonstrate that the batch meets all specifications and that any deviations were investigated and resolved.
The BPR ensures that operators do not deviate from the process. By requiring sign-offs at every step (e.g., checking temperature, verifying weight), it creates a system of checks and balances that prevents errors from compounding. batch production records