January 26, 2016

Batch Production Record

A Batch Production Record is derived from a Master Production Record that is used to document the specific information for each individual batch. For Medical Device manufacturers, learn more about Device History Records.

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InstantGMP Batch Production Records (BPR)

  • Batch records include: Cover Page, Bill of Materials, Equipment List, In Process Testing, Manufacturing Instructions, and BPR Review
  • Manufacturing instructions allow for the entry of step results in real-time during manufacturing with operator signature prompts and automated time/date stamps
  • BPR Reviewers can Approve or Reject a BPR
  • Once a Batch has been manufactured, it can be added to inventory
  • BPRs are generated from the Master Production Record with one click
  • Batch Records can be locked and unlocked via digital signatures
  • A history of all status changes and signatures are kept for complete traceability
  • Color-coded status icons simplify review of a BPR’s status
  • BPRs can be exported as PDFs
  • InstantGMP™ Batch Production Records are fully integrated with Inventory Management, Room Logs, Equipment Logs, and Document Management

InstantGMP™ generates batch production records that keep track of:

  • Unique Batch and Production numbers
  • When a product is planned for production
  • When a product was produced
  • The quantities of raw materials and ingredients that went into a batch
  • Which lots of raw materials and ingredients were used
  • The actual manufacturing steps that were followed and the results obtained
  • Any deviations that were investigated and resolved
  • Electronic time-stamped signatures of performers, reviewers and quality